Demo logical data model
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Demo logical data model, published by My Organization. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/wgroup6/11615 and changes regularly. See the Directory of published versions

Logical Model: IDMP11615Authorised - Detailed Descriptions

Active as of 2023-10-31

Definitions for the MedicinalProduct logical model.

Guidance on how to interpret the contents of this table can be found here

0. MedicinalProduct
Definition

ISO 11615 Authorised Medicinal Product

Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. MedicinalProduct.MPID
Definition

This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)

ShortThis is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)
Control1..1
TypeElement(II)
4. MedicinalProduct.CombinedPharmaceuticalDoseForm
Definition

The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)

ShortThe combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)
Control0..1
TypeElement(CD)
6. MedicinalProduct.AdditionalMonitoringIndicator
Definition

If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)

ShortIf the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)
Control0..1
TypeElement(CD)
8. MedicinalProduct.SpecialMeasures
Definition

If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)

ShortIf the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)
Control0..*
TypeElement(ST)
10. MedicinalProduct.PaediatricUseIndicator
Definition

This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)

ShortThis is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)
Control0..1
TypeElement(CD)
12. MedicinalProduct.OrphanDesignationStatus
Definition

The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)

ShortThe description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)
Control0..1
TypeElement(CD)
14. MedicinalProduct.AttachedDocument
Definition

9.2.2.11

Short9.2.2.11
Control1..*
TypeBackboneElement(Class)
16. MedicinalProduct.AttachedDocument.Identifier
Definition

The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)

ShortThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
Control1..1
TypeElement(II)
18. MedicinalProduct.AttachedDocument.EffectiveDate
Definition

The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)

ShortThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
Control1..1
TypeElement(DT)
20. MedicinalProduct.AttachedDocument.Type
Definition

The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)

ShortThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
Control1..1
TypeElement(CD)
22. MedicinalProduct.AttachedDocument.Content
Definition

The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)

ShortThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
Control1..1
TypeElement(ED)
24. MedicinalProduct.AttachedDocument.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
Control0..1
TypeElement(CD)
26. MedicinalProduct.AttachedDocument.MediaType
Definition

This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)

ShortThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
Control0..1
TypeElement(CD)
28. MedicinalProduct.AttachedDocument.VersionNumber
Definition

This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)

ShortThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
Control0..1
TypeElement(ST)
30. MedicinalProduct.AttachedDocument.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)

ShortThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
Control0..1
TypeElement(II)
32. MedicinalProduct.Contraindication
Definition

9.9.2.3

Short9.9.2.3
Control0..*
TypeBackboneElement(Class)
34. MedicinalProduct.Contraindication.ContraindicationsText
Definition

The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)

ShortThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
Control1..1
TypeElement(ST)
36. MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)

ShortThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
Control0..1
TypeElement(CD)
38. MedicinalProduct.Contraindication.DiseaseStatus
Definition

The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)

ShortThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
Control0..1
TypeElement(CD)
40. MedicinalProduct.Contraindication.Comorbidity
Definition

The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)

ShortThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
Control0..*
TypeElement(CD)
42. MedicinalProduct.Contraindication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement(Class)
44. MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeElement(CD)
46. MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeElement(CD)
48. MedicinalProduct.Contraindication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
50. MedicinalProduct.Contraindication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
52. MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
54. MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
56. MedicinalProduct.Contraindication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
58. MedicinalProduct.Contraindication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
60. MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
62. MedicinalProduct.Contraindication.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control0..*
TypeBackboneElement(Class)
64. MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
TypeElement(ST)
66. MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeElement(CD)
68. MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeElement(CD)
70. MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeElement(CD)
72. MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeElement(CD)
74. MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeElement(PQ)
76. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement(Class)
78. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeElement(CD)
80. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeElement(CD)
82. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement(Class)
84. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
86. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
88. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
90. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
92. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
94. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
96. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement(Class)
98. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
TypeElement(ST)
100. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeElement(CD)
102. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeElement(CD)
104. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeElement(CD)
106. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
108. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
110. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
112. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
114. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
116. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
118. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
120. MedicinalProduct.Header
Definition

9.2.2.10

Short9.2.2.10
Control1..1
TypeBackboneElement(Class)
122. MedicinalProduct.Header.Identifier
Definition

This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)

ShortThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
Control1..1
TypeElement(II)
124. MedicinalProduct.Header.EffectiveDate
Definition

The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)

ShortThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
Control1..1
TypeElement(DT)
126. MedicinalProduct.Header.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
Control0..1
TypeElement(CD)
128. MedicinalProduct.Header.VersionNumber
Definition

This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)

ShortThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
Control0..1
TypeElement(ST)
130. MedicinalProduct.Header.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)

ShortThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
Control0..1
TypeElement(II)
132. MedicinalProduct.Interactions
Definition

9.9.2.7

Short9.9.2.7
Control0..*
TypeBackboneElement(Class)
134. MedicinalProduct.Interactions.InteractionsText
Definition

The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)

ShortThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
Control1..1
TypeElement(ST)
136. MedicinalProduct.Interactions.Interactant
Definition

This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)

ShortThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
Control0..*
TypeElement(CD)
138. MedicinalProduct.Interactions.InteractionsType
Definition

The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)

ShortThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
Control0..1
TypeElement(CD)
140. MedicinalProduct.Interactions.InteractionsEffect
Definition

The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)

ShortThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
Control0..1
TypeElement(CD)
142. MedicinalProduct.Interactions.InteractionsIncidence
Definition

The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)

ShortThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
Control0..1
TypeElement(CD)
144. MedicinalProduct.Interactions.ManagementActions
Definition

The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)

ShortThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
Control0..1
TypeElement(CD)
146. MedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control1..*
TypeBackboneElement(Class)
148. MedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
150. MedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
152. MedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
154. MedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
156. MedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
158. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
160. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
162. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
164. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
166. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
168. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
170. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
172. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
174. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
176. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
178. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
180. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
182. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
184. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
186. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
188. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
190. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
192. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
194. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
196. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
198. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
200. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
202. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
204. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
206. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
208. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
210. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
212. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
214. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
216. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
218. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
220. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
222. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
224. MedicinalProduct.MarketingAuthorisation
Definition

9.3.2.2

Short9.3.2.2
Control1..1
TypeBackboneElement(Class)
226. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)

ShortThe number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)
Control1..1
TypeElement(II)
228. MedicinalProduct.MarketingAuthorisation.Country
Definition

The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)

ShortThe country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)
Control1..*
TypeElement(CD)
230. MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)

ShortThe legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)
Control1..1
TypeElement(CD)
232. MedicinalProduct.MarketingAuthorisation.AuthorisationStatus
Definition

The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)

ShortThe status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)
Control1..1
TypeElement(CD)
234. MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate
Definition

The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)

ShortThe date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)
Control1..1
TypeElement(DT)
236. MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart
Definition

The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)

ShortThe beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)
Control1..1
TypeElement(DT)
238. MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd
Definition

The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)

ShortThe end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)
Control1..1
TypeElement(DT)
240. MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate
Definition

The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)

ShortThe “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)
Control0..1
TypeElement(DT)
242. MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate
Definition

The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)

ShortThe end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)
Control0..1
TypeElement(DT)
244. MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation
Definition

The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)

ShortThe date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)
Control0..1
TypeElement(DT)
246. MedicinalProduct.MarketingAuthorisation.InternationalBirthDate
Definition

This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)

ShortThis is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)
Control1..1
TypeElement(DT)
248. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation
Definition

9.3.2.10

Short9.3.2.10
Control0..*
TypeBackboneElement(Class)
250. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country
Definition

This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)

ShortThis attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)
Control1..1
TypeElement(CD)
252. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction
Definition

This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)

ShortThis attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)
Control0..1
TypeElement(CD)
254. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)

ShortThe number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)
Control0..1
TypeElement(II)
256. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)

ShortThe legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)
Control0..1
TypeElement(CD)
258. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation
Definition

9.3.2.3

Short9.3.2.3
Control1..1
TypeBackboneElement(Class)
260. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
262. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
264. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
266. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
268. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
270. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
272. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
274. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
276. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
278. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
280. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
282. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
284. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
286. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
288. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
290. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
292. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME
Definition

9.3.2.4

Short9.3.2.4
Control0..1
TypeBackboneElement(Class)
294. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag
Definition

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

ShortThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
Control1..1
TypeElement(BL)
296. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size
Definition

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

ShortThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
Control0..1
TypeElement(CD)
298. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber
Definition

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

ShortThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
Control0..1
TypeElement(II)
300. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate
Definition

This is the date when the SME status was granted. (9.3.2.4.4)

ShortThis is the date when the SME status was granted. (9.3.2.4.4)
Control0..1
TypeElement(DT)
302. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure
Definition

9.3.2.6

Short9.3.2.6
Control1..1
TypeBackboneElement(Class)
304. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number
Definition

The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)

ShortThe unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)
Control0..1
TypeElement(II)
306. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType
Definition

The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)

ShortThe type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)
Control1..1
TypeElement(CD)
308. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart
Definition

The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)

ShortThe initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)
Control0..1
TypeElement(DT)
310. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd
Definition

The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)

ShortThe end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)
Control0..1
TypeElement(DT)
312. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication
Definition

9.3.2.7

Short9.3.2.7
Control0..*
TypeBackboneElement(Class)
314. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number
Definition

A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)

ShortA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)
Control1..1
TypeElement(II)
316. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType
Definition

The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)

ShortThe type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)
Control1..1
TypeElement(CD)
318. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate
Definition

The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)

ShortThe date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)
Control1..1
TypeElement(DT)
320. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control1..1
TypeBackboneElement(Class)
322. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
324. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
326. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
328. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
330. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
332. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
334. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
336. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
338. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
340. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
342. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
344. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
346. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
348. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
350. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
352. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
354. MedicinalProduct.MarketingAuthorisation.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
356. MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
358. MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
360. MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
362. MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
364. MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
366. MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
368. MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
370. MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
372. MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
374. MedicinalProduct.MarketingStatus
Definition

9.3.2.8

Short9.3.2.8
Control0..*
TypeBackboneElement(Class)
376. MedicinalProduct.MarketingStatus.Country
Definition

The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)

ShortThe country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)
Control1..1
TypeElement(CD)
378. MedicinalProduct.MarketingStatus.Jurisdiction
Definition

Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)

ShortWhere a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)
Control0..1
TypeElement(CD)
380. MedicinalProduct.MarketingStatus.MarketingStatus
Definition

This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)

ShortThis attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)
Control1..1
TypeElement(CD)
382. MedicinalProduct.MarketingStatus.MarketingDateStart
Definition

The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)

ShortThe date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)
Control1..1
TypeElement(DT)
384. MedicinalProduct.MarketingStatus.MarketingDateStop
Definition

The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)

ShortThe date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)
Control1..1
TypeElement(DT)
386. MedicinalProduct.MarketingStatus.RiskOfSupplyShortage
Definition

Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)

ShortIndication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)
Control0..1
TypeElement(BL)
388. MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment
Definition

Any additional comment on supply shortage. (9.3.2.8.8)

ShortAny additional comment on supply shortage. (9.3.2.8.8)
Control0..1
TypeElement(ST)
390. MedicinalProduct.MarketingStatus.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
392. MedicinalProduct.MarketingStatus.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
394. MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
396. MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
398. MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
400. MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
402. MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
404. MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
406. MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
408. MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
410. MedicinalProduct.MasterFile
Definition

9.2.2.5

Short9.2.2.5
Control0..*
TypeBackboneElement(Class)
412. MedicinalProduct.MasterFile.FileType
Definition

This attribute is to define which kind of master file is indicated (9.2.2.5.2)

ShortThis attribute is to define which kind of master file is indicated (9.2.2.5.2)
Control1..1
TypeElement(CD)
414. MedicinalProduct.MasterFile.FileCode
Definition

This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)

ShortThis attribute is for a code to uniquely identify a master file. (9.2.2.5.3)
Control1..1
TypeElement(II)
416. MedicinalProduct.MasterFile.MasterFileHolder-Organisation
Definition

9.2.2.6

Short9.2.2.6
Control0..1
TypeBackboneElement(Class)
418. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
420. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
422. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
424. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
426. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
428. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
430. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
432. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
434. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
436. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
438. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
440. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
442. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
444. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
446. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
448. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
450. MedicinalProduct.MedicinalProductName
Definition

9.2.2.8

Short9.2.2.8
Control1..*
TypeBackboneElement(Class)
452. MedicinalProduct.MedicinalProductName.FullName
Definition

The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)

ShortThe full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)
Control1..1
TypeElement(ST)
454. MedicinalProduct.MedicinalProductName.InventedNamePart
Definition

The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)

ShortThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
Control0..*
TypeElement(ST)
456. MedicinalProduct.MedicinalProductName.ScientificNamePart
Definition

The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)

ShortThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
Control0..*
TypeElement(ST)
458. MedicinalProduct.MedicinalProductName.StrengthPart
Definition

The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)

ShortThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
Control0..*
TypeElement(ST)
460. MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart
Definition

The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)

ShortThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
Control0..*
TypeElement(ST)
462. MedicinalProduct.MedicinalProductName.FormulationPart
Definition

The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)

ShortThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
Control0..*
TypeElement(ST)
464. MedicinalProduct.MedicinalProductName.IntendedUsePart
Definition

The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)

ShortThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
Control0..*
TypeElement(ST)
466. MedicinalProduct.MedicinalProductName.TargetPopulationPart
Definition

The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)

ShortThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
Control0..*
TypeElement(ST)
468. MedicinalProduct.MedicinalProductName.ContainerOrPackPart
Definition

The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)

ShortThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
Control0..*
TypeElement(ST)
470. MedicinalProduct.MedicinalProductName.DevicePart
Definition

The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)

ShortThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
Control0..*
TypeElement(ST)
472. MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart
Definition

The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)

ShortThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
Control0..*
TypeElement(ST)
474. MedicinalProduct.MedicinalProductName.Time-PeriodPart
Definition

The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)

ShortThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
Control0..*
TypeElement(ST)
476. MedicinalProduct.MedicinalProductName.FlavourPart
Definition

The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)

ShortThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
Control0..*
TypeElement(ST)
478. MedicinalProduct.MedicinalProductName.DelimiterPart
Definition

A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)

ShortA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
Control0..*
TypeElement(ST)
480. MedicinalProduct.MedicinalProductName.Country-Language
Definition

9.2.2.9

Short9.2.2.9
Control1..*
TypeBackboneElement(Class)
482. MedicinalProduct.MedicinalProductName.Country-Language.Country
Definition

The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)

ShortThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
Control1..1
TypeElement(CD)
484. MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction
Definition

The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)

ShortThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
Control0..1
TypeElement(CD)
486. MedicinalProduct.MedicinalProductName.Country-Language.Language
Definition

The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)

ShortThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
Control1..1
TypeElement(CD)
488. MedicinalProduct.OrphanDesignation
Definition

9.2.2.3

Short9.2.2.3
Control0..*
TypeBackboneElement(Class)
490. MedicinalProduct.OrphanDesignation.OrphanIndicationType
Definition

This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)

ShortThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
Control1..1
TypeElement(CD)
492. MedicinalProduct.OrphanDesignation.OrphanProcedureNumber
Definition

This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)

ShortThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
Control0..1
TypeElement(II)
494. MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus
Definition

This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)

ShortThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
Control1..1
TypeElement(CD)
496. MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate
Definition

This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)

ShortThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
Control0..1
TypeElement(DT)
498. MedicinalProduct.OrphanDesignation.OrphanDesignationNumber
Definition

This field is to indicate the orphan designation decision number. (9.2.2.3.6)

ShortThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
Control0..1
TypeElement(II)
500. MedicinalProduct.PackagedMedicinalProduct
Definition

9.6.2.2

Short9.6.2.2
Control1..*
TypeBackboneElement(Class)
502. MedicinalProduct.PackagedMedicinalProduct.PCID
Definition

This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)

ShortThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
Control1..1
TypeElement(II)
504. MedicinalProduct.PackagedMedicinalProduct.PackageDescription
Definition

A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)

ShortA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
Control1..1
TypeElement(ST)
506. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier
Definition

9.6.2.8

Short9.6.2.8
Control0..*
TypeBackboneElement(Class)
508. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1
Definition

The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)

ShortThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
Control1..1
TypeElement(II)
510. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2
Definition

The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)

ShortThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
Control0..1
TypeElement(II)
512. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate
Definition

This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)

ShortThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
Control1..1
TypeElement(DT)
514. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
516. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
518. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
520. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
522. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
524. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
526. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
528. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
530. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
532. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
534. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
536. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
538. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
540. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
542. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
544. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
546. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
548. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
550. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
552. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
554. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
556. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
558. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
560. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
562. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
564. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
566. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
568. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
570. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
572. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
574. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
576. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
578. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
580. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
582. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
584. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
586. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
588. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
590. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
592. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation
Definition

9.3.2.2

Short9.3.2.2
Control0..1
TypeBackboneElement(Class)
594. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)

ShortThe number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)
Control1..1
TypeElement(II)
596. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country
Definition

The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)

ShortThe country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)
Control1..*
TypeElement(CD)
598. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)

ShortThe legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)
Control1..1
TypeElement(CD)
600. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus
Definition

The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)

ShortThe status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)
Control1..1
TypeElement(CD)
602. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate
Definition

The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)

ShortThe date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)
Control1..1
TypeElement(DT)
604. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart
Definition

The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)

ShortThe beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)
Control1..1
TypeElement(DT)
606. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd
Definition

The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)

ShortThe end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)
Control1..1
TypeElement(DT)
608. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate
Definition

The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)

ShortThe “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)
Control0..1
TypeElement(DT)
610. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate
Definition

The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)

ShortThe end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)
Control0..1
TypeElement(DT)
612. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation
Definition

The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)

ShortThe date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)
Control0..1
TypeElement(DT)
614. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate
Definition

This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)

ShortThis is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)
Control1..1
TypeElement(DT)
616. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation
Definition

9.3.2.10

Short9.3.2.10
Control0..*
TypeBackboneElement(Class)
618. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country
Definition

This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)

ShortThis attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)
Control1..1
TypeElement(CD)
620. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction
Definition

This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)

ShortThis attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)
Control0..1
TypeElement(CD)
622. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)

ShortThe number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)
Control0..1
TypeElement(II)
624. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)

ShortThe legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)
Control0..1
TypeElement(CD)
626. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation
Definition

9.3.2.3

Short9.3.2.3
Control1..1
TypeBackboneElement(Class)
628. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
630. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
632. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
634. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
636. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
638. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
640. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
642. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
644. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
646. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
648. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
650. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
652. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
654. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
656. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
658. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
660. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME
Definition

9.3.2.4

Short9.3.2.4
Control0..1
TypeBackboneElement(Class)
662. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag
Definition

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

ShortThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
Control1..1
TypeElement(BL)
664. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size
Definition

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

ShortThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
Control0..1
TypeElement(CD)
666. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber
Definition

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

ShortThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
Control0..1
TypeElement(II)
668. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate
Definition

This is the date when the SME status was granted. (9.3.2.4.4)

ShortThis is the date when the SME status was granted. (9.3.2.4.4)
Control0..1
TypeElement(DT)
670. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure
Definition

9.3.2.6

Short9.3.2.6
Control1..1
TypeBackboneElement(Class)
672. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number
Definition

The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)

ShortThe unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)
Control0..1
TypeElement(II)
674. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType
Definition

The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)

ShortThe type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)
Control1..1
TypeElement(CD)
676. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart
Definition

The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)

ShortThe initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)
Control0..1
TypeElement(DT)
678. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd
Definition

The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)

ShortThe end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)
Control0..1
TypeElement(DT)
680. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication
Definition

9.3.2.7

Short9.3.2.7
Control0..*
TypeBackboneElement(Class)
682. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number
Definition

A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)

ShortA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)
Control1..1
TypeElement(II)
684. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType
Definition

The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)

ShortThe type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)
Control1..1
TypeElement(CD)
686. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate
Definition

The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)

ShortThe date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)
Control1..1
TypeElement(DT)
688. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control1..1
TypeBackboneElement(Class)
690. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
692. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
694. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
696. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
698. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
700. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
702. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
704. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
706. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
708. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
710. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
712. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
714. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
716. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
718. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
720. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
722. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
724. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
726. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
728. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
730. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
732. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
734. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
736. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
738. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
740. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
742. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus
Definition

9.3.2.8

Short9.3.2.8
Control0..*
TypeBackboneElement(Class)
744. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country
Definition

The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)

ShortThe country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)
Control1..1
TypeElement(CD)
746. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction
Definition

Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)

ShortWhere a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)
Control0..1
TypeElement(CD)
748. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus
Definition

This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)

ShortThis attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)
Control1..1
TypeElement(CD)
750. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart
Definition

The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)

ShortThe date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)
Control1..1
TypeElement(DT)
752. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop
Definition

The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)

ShortThe date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)
Control1..1
TypeElement(DT)
754. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage
Definition

Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)

ShortIndication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)
Control0..1
TypeElement(BL)
756. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment
Definition

Any additional comment on supply shortage. (9.3.2.8.8)

ShortAny additional comment on supply shortage. (9.3.2.8.8)
Control0..1
TypeElement(ST)
758. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
760. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
762. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
764. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
766. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
768. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
770. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
772. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
774. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
776. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
778. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container
Definition

9.6.2.3

Short9.6.2.3
Control1..*
TypeBackboneElement(Class)
780. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType
Definition

The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)

ShortThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
Control1..1
TypeElement(CD)
782. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity
Definition

The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)

ShortThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
Control1..1
TypeElement(PQ)
784. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Material
Definition

The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)

ShortThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
Control1..*
TypeElement(CD)
786. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.AlternateMaterial
Definition

The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)

ShortThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
Control0..*
TypeElement(CD)
788. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier
Definition

9.6.2.4

Short9.6.2.4
Control0..*
TypeBackboneElement(Class)
790. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem
Definition

The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)

ShortThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
Control1..1
TypeElement(CD)
792. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value
Definition

The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)

ShortThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
Control1..1
TypeElement(CD)
794. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement(Class)
796. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeElement(CD)
798. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
TypeElement(ST)
800. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeElement(PQ)
802. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
TypeElement(ST)
804. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeElement(II)
806. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
TypeElement(ST)
808. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeElement(CD)
810. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeElement(CD)
812. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeElement(CD)
814. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier
Definition

9.6.2.15

Short9.6.2.15
Control0..*
TypeBackboneElement(Class)
816. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
TypeElement(ST)
818. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
TypeElement(DT)
820. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement(Class)
822. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeElement(CD)
824. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
826. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
828. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature
Definition

9.6.2.14

Short9.6.2.14
Control0..*
TypeBackboneElement(Class)
830. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeElement(CD)
832. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeElement(CD)
834. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
836. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
838. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
840. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
842. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
844. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
846. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
848. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
850. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
852. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
854. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
856. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
858. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
860. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
862. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
864. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
866. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
868. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
870. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
872. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
874. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
876. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
878. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
880. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
882. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
884. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
886. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
888. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
890. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
892. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
894. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
896. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
898. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
900. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
902. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
904. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
906. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
908. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
910. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
912. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
914. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
916. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
918. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
920. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
922. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
924. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
926. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
928. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
930. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
932. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
934. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
936. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
938. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
940. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
942. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement(Class)
944. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeElement(CD)
946. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeElement(PQ)
948. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeElement(CD)
950. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem
Definition

9.6.2.20

Short9.6.2.20
Control0..*
TypeBackboneElement(Class)
952. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm
Definition

This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)

ShortThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
Control1..1
TypeElement(CD)
954. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation
Definition

This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)

ShortThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
Control0..1
TypeElement(CD)
956. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity
Definition

The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)

ShortThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
Control1..1
TypeElement(PQ)
958. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient
Definition

9.7.2.2

Short9.7.2.2
Control1..*
TypeBackboneElement(Class)
960. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeElement(CD)
962. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
964. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
966. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
968. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
970. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
972. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
974. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
976. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
978. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
980. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
982. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
984. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
986. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
988. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
990. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
992. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
994. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
996. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
998. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
1000. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1002. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1004. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1006. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1008. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
1010. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1012. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1014. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1016. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1018. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1020. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1022. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1024. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1026. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1028. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1030. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1032. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1034. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1036. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1038. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1040. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1042. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement(Class)
1044. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeElement(CD)
1046. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeElement(CD)
1048. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeElement(CD)
1050. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement(Class)
1052. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
1054. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
1056. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
1058. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
1060. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
1062. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
1064. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
1066. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
1068. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
1070. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
1072. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement(Class)
1074. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeElement(CD)
1076. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement(Class)
1078. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
1080. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
1082. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
1084. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
1086. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
1088. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
1090. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
1092. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
1094. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
1096. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
1098. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
1100. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1102. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1104. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1106. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1108. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1110. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1112. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1114. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1116. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1118. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1120. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1122. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1124. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1126. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1128. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1130. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1132. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
1134. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1136. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1138. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1140. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1142. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
1144. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1146. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1148. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1150. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1152. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1154. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1156. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1158. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1160. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1162. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1164. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1166. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1168. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1170. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1172. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1174. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1176. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
1178. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1180. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1182. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
1184. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1186. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1188. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1190. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1192. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1194. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1196. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1198. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1200. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1202. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1204. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1206. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
1208. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1210. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1212. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1214. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1216. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1218. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1220. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1222. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1224. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1226. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1228. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1230. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1232. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1234. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1236. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1238. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1240. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
1242. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1244. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1246. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1248. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1250. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
1252. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1254. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1256. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1258. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1260. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1262. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1264. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1266. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1268. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1270. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1272. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1274. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1276. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1278. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1280. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1282. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1284. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
1286. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1288. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1290. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component
Definition

9.6.2.9

Short9.6.2.9
Control0..*
TypeBackboneElement(Class)
1292. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType
Definition

The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)

ShortThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
Control1..1
TypeElement(CD)
1294. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial
Definition

The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)

ShortThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
Control0..*
TypeElement(CD)
1296. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial
Definition

Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)

ShortAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
Control0..*
TypeElement(CD)
1298. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
1300. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1302. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1304. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1306. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1308. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1310. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1312. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1314. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1316. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1318. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1320. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1322. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1324. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1326. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1328. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1330. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1332. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
1334. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1336. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1338. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1340. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1342. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
1344. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1346. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1348. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1350. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1352. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1354. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1356. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1358. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1360. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1362. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1364. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1366. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1368. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1370. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1372. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1374. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1376. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
1378. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1380. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1382. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1384. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1386. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1388. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1390. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1392. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1394. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1396. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1398. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1400. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
1402. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1404. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1406. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1408. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1410. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1412. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1414. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1416. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1418. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1420. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1422. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1424. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement(Class)
1426. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeElement(CD)
1428. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeElement(PQ)
1430. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeElement(CD)
1432. MedicinalProduct.PharmaceuticalProduct
Definition

9.8.2.2

Short9.8.2.2
Control1..*
TypeBackboneElement(Class)
1434. MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm
Definition

This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)

ShortThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
Control1..1
TypeElement(CD)
1436. MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation
Definition

The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)

ShortThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
Control0..1
TypeElement(CD)
1438. MedicinalProduct.PharmaceuticalProduct.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement(Class)
1440. MedicinalProduct.PharmaceuticalProduct.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeElement(CD)
1442. MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
TypeElement(ST)
1444. MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeElement(PQ)
1446. MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
TypeElement(ST)
1448. MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeElement(II)
1450. MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
TypeElement(ST)
1452. MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeElement(CD)
1454. MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeElement(CD)
1456. MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeElement(CD)
1458. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier
Definition

9.6.2.15

Short9.6.2.15
Control0..*
TypeBackboneElement(Class)
1460. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
TypeElement(ST)
1462. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
TypeElement(DT)
1464. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement(Class)
1466. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeElement(CD)
1468. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
1470. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
1472. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature
Definition

9.6.2.14

Short9.6.2.14
Control0..*
TypeBackboneElement(Class)
1474. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeElement(CD)
1476. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeElement(CD)
1478. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
1480. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1482. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1484. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1486. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1488. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1490. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1492. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1494. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1496. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1498. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1500. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1502. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1504. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1506. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1508. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1510. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1512. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
1514. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1516. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1518. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1520. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1522. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
1524. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1526. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1528. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1530. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1532. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1534. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1536. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1538. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1540. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1542. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1544. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1546. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1548. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1550. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1552. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1554. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1556. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
1558. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1560. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1562. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
1564. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1566. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1568. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1570. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1572. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1574. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1576. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1578. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1580. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1582. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1584. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1586. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement(Class)
1588. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeElement(CD)
1590. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeElement(PQ)
1592. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeElement(CD)
1594. MedicinalProduct.PharmaceuticalProduct.Ingredient
Definition

9.7.2.2

Short9.7.2.2
Control1..*
TypeBackboneElement(Class)
1596. MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeElement(CD)
1598. MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
1600. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
1602. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1604. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1606. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1608. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1610. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1612. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1614. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1616. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1618. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1620. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1622. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1624. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1626. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1628. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1630. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1632. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1634. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
1636. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1638. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1640. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1642. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1644. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
1646. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1648. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1650. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1652. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1654. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1656. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
1658. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1660. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1662. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1664. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1666. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
1668. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1670. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1672. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1674. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1676. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1678. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement(Class)
1680. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeElement(CD)
1682. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeElement(CD)
1684. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeElement(CD)
1686. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement(Class)
1688. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
1690. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
1692. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
1694. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
1696. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
1698. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
1700. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
1702. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
1704. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
1706. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
1708. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement(Class)
1710. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeElement(CD)
1712. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement(Class)
1714. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
1716. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
1718. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
1720. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
1722. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
1724. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
1726. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
1728. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
1730. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
1732. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
1734. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics
Definition

9.8.2.4

Short9.8.2.4
Control0..*
TypeBackboneElement(Class)
1736. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem
Definition

The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)

ShortThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
Control1..1
TypeElement(CD)
1738. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value
Definition

The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)

ShortThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
Control1..1
TypeElement(CD)
1740. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status
Definition

The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)

ShortThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
Control0..1
TypeElement(CD)
1742. MedicinalProduct.PharmaceuticalProduct.PhPIDSet
Definition

9.8.2.6

Short9.8.2.6
Control1..*
TypeBackboneElement(Class)
1744. MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets
Definition

This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)

ShortThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
Control1..1
TypeElement(II)
1746. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration
Definition

9.8.2.3

Short9.8.2.3
Control1..*
TypeBackboneElement(Class)
1748. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration
Definition

The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)

ShortThe route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)
Control1..1
TypeElement(CD)
1750. MedicinalProduct.ProductClassification
Definition

9.2.2.4

Short9.2.2.4
Control0..*
TypeBackboneElement(Class)
1752. MedicinalProduct.ProductClassification.CodeSystem
Definition

The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)

ShortThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
Control1..1
TypeElement(CD)
1754. MedicinalProduct.ProductClassification.Value
Definition

The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)

ShortThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
Control1..1
TypeElement(CD)
1756. MedicinalProduct.ProductCross-Reference
Definition

9.2.2.7

Short9.2.2.7
Control0..*
TypeBackboneElement(Class)
1758. MedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference
Definition

This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)

ShortThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
Control1..1
TypeElement(II)
1760. MedicinalProduct.ProductCross-Reference.ReferencedProductType
Definition

This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)

ShortThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
Control0..1
TypeElement(CD)
1762. MedicinalProduct.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control1..*
TypeBackboneElement(Class)
1764. MedicinalProduct.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
TypeElement(ST)
1766. MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeElement(CD)
1768. MedicinalProduct.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeElement(CD)
1770. MedicinalProduct.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeElement(CD)
1772. MedicinalProduct.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeElement(CD)
1774. MedicinalProduct.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeElement(PQ)
1776. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement(Class)
1778. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeElement(CD)
1780. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeElement(CD)
1782. MedicinalProduct.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement(Class)
1784. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
1786. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
1788. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
1790. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
1792. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
1794. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
1796. MedicinalProduct.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement(Class)
1798. MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
TypeElement(ST)
1800. MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeElement(CD)
1802. MedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeElement(CD)
1804. MedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeElement(CD)
1806. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
1808. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
1810. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
1812. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
1814. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
1816. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
1818. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
1820. MedicinalProduct.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement(Class)
1822. MedicinalProduct.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
TypeElement(ST)
1824. MedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeElement(CD)
1826. MedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeElement(CD)
1828. MedicinalProduct.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeElement(CD)
1830. MedicinalProduct.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
1832. MedicinalProduct.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
1834. MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
1836. MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
1838. MedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
1840. MedicinalProduct.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
1842. MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)

Guidance on how to interpret the contents of this table can be found here

0. MedicinalProduct
Definition

ISO 11615 Authorised Medicinal Product

Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. MedicinalProduct.MPID
Definition

This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)

ShortThis is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)
Control1..1
TypeElement(II)
4. MedicinalProduct.CombinedPharmaceuticalDoseForm
Definition

The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)

ShortThe combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)
Control0..1
TypeElement(CD)
6. MedicinalProduct.AdditionalMonitoringIndicator
Definition

If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)

ShortIf the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)
Control0..1
TypeElement(CD)
8. MedicinalProduct.SpecialMeasures
Definition

If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)

ShortIf the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)
Control0..*
TypeElement(ST)
10. MedicinalProduct.PaediatricUseIndicator
Definition

This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)

ShortThis is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)
Control0..1
TypeElement(CD)
12. MedicinalProduct.OrphanDesignationStatus
Definition

The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)

ShortThe description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)
Control0..1
TypeElement(CD)
14. MedicinalProduct.AttachedDocument
Definition

9.2.2.11

Short9.2.2.11
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. MedicinalProduct.AttachedDocument.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. MedicinalProduct.AttachedDocument.Identifier
Definition

The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)

ShortThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
Control1..1
TypeElement(II)
20. MedicinalProduct.AttachedDocument.EffectiveDate
Definition

The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)

ShortThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
Control1..1
TypeElement(DT)
22. MedicinalProduct.AttachedDocument.Type
Definition

The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)

ShortThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
Control1..1
TypeElement(CD)
24. MedicinalProduct.AttachedDocument.Content
Definition

The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)

ShortThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
Control1..1
TypeElement(ED)
26. MedicinalProduct.AttachedDocument.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
Control0..1
TypeElement(CD)
28. MedicinalProduct.AttachedDocument.MediaType
Definition

This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)

ShortThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
Control0..1
TypeElement(CD)
30. MedicinalProduct.AttachedDocument.VersionNumber
Definition

This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)

ShortThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
Control0..1
TypeElement(ST)
32. MedicinalProduct.AttachedDocument.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)

ShortThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
Control0..1
TypeElement(II)
34. MedicinalProduct.Contraindication
Definition

9.9.2.3

Short9.9.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. MedicinalProduct.Contraindication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
38. MedicinalProduct.Contraindication.ContraindicationsText
Definition

The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)

ShortThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
Control1..1
TypeElement(ST)
40. MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)

ShortThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
Control0..1
TypeElement(CD)
42. MedicinalProduct.Contraindication.DiseaseStatus
Definition

The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)

ShortThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
Control0..1
TypeElement(CD)
44. MedicinalProduct.Contraindication.Comorbidity
Definition

The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)

ShortThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
Control0..*
TypeElement(CD)
46. MedicinalProduct.Contraindication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. MedicinalProduct.Contraindication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
50. MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeElement(CD)
52. MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeElement(CD)
54. MedicinalProduct.Contraindication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. MedicinalProduct.Contraindication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
58. MedicinalProduct.Contraindication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
60. MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
62. MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
64. MedicinalProduct.Contraindication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
66. MedicinalProduct.Contraindication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
68. MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
70. MedicinalProduct.Contraindication.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. MedicinalProduct.Contraindication.TherapeuticIndication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
74. MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
TypeElement(ST)
76. MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeElement(CD)
78. MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeElement(CD)
80. MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeElement(CD)
82. MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeElement(CD)
84. MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeElement(PQ)
86. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
90. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeElement(CD)
92. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeElement(CD)
94. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
98. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
100. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
102. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
104. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
106. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
108. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
110. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
114. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
TypeElement(ST)
116. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeElement(CD)
118. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeElement(CD)
120. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeElement(CD)
122. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
124. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
126. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
128. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
130. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
132. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
134. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
136. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
138. MedicinalProduct.Header
Definition

9.2.2.10

Short9.2.2.10
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
140. MedicinalProduct.Header.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
142. MedicinalProduct.Header.Identifier
Definition

This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)

ShortThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
Control1..1
TypeElement(II)
144. MedicinalProduct.Header.EffectiveDate
Definition

The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)

ShortThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
Control1..1
TypeElement(DT)
146. MedicinalProduct.Header.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
Control0..1
TypeElement(CD)
148. MedicinalProduct.Header.VersionNumber
Definition

This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)

ShortThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
Control0..1
TypeElement(ST)
150. MedicinalProduct.Header.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)

ShortThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
Control0..1
TypeElement(II)
152. MedicinalProduct.Interactions
Definition

9.9.2.7

Short9.9.2.7
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
154. MedicinalProduct.Interactions.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
156. MedicinalProduct.Interactions.InteractionsText
Definition

The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)

ShortThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
Control1..1
TypeElement(ST)
158. MedicinalProduct.Interactions.Interactant
Definition

This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)

ShortThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
Control0..*
TypeElement(CD)
160. MedicinalProduct.Interactions.InteractionsType
Definition

The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)

ShortThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
Control0..1
TypeElement(CD)
162. MedicinalProduct.Interactions.InteractionsEffect
Definition

The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)

ShortThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
Control0..1
TypeElement(CD)
164. MedicinalProduct.Interactions.InteractionsIncidence
Definition

The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)

ShortThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
Control0..1
TypeElement(CD)
166. MedicinalProduct.Interactions.ManagementActions
Definition

The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)

ShortThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
Control0..1
TypeElement(CD)
168. MedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
170. MedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
172. MedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
174. MedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
176. MedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
178. MedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
180. MedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
182. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
184. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
186. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
188. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
190. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
192. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
194. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
196. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
198. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
200. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
202. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
204. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
206. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
208. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
210. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
212. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
214. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
216. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
218. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
220. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
222. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
224. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
226. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
228. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
230. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
232. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
234. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
236. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
238. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
240. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
242. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
244. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
246. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
248. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
250. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
252. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
254. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
256. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
258. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
260. MedicinalProduct.MarketingAuthorisation
Definition

9.3.2.2

Short9.3.2.2
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
262. MedicinalProduct.MarketingAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
264. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)

ShortThe number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)
Control1..1
TypeElement(II)
266. MedicinalProduct.MarketingAuthorisation.Country
Definition

The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)

ShortThe country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)
Control1..*
TypeElement(CD)
268. MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)

ShortThe legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)
Control1..1
TypeElement(CD)
270. MedicinalProduct.MarketingAuthorisation.AuthorisationStatus
Definition

The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)

ShortThe status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)
Control1..1
TypeElement(CD)
272. MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate
Definition

The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)

ShortThe date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)
Control1..1
TypeElement(DT)
274. MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart
Definition

The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)

ShortThe beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)
Control1..1
TypeElement(DT)
276. MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd
Definition

The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)

ShortThe end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)
Control1..1
TypeElement(DT)
278. MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate
Definition

The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)

ShortThe “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)
Control0..1
TypeElement(DT)
280. MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate
Definition

The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)

ShortThe end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)
Control0..1
TypeElement(DT)
282. MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation
Definition

The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)

ShortThe date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)
Control0..1
TypeElement(DT)
284. MedicinalProduct.MarketingAuthorisation.InternationalBirthDate
Definition

This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)

ShortThis is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)
Control1..1
TypeElement(DT)
286. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation
Definition

9.3.2.10

Short9.3.2.10
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
288. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
290. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country
Definition

This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)

ShortThis attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)
Control1..1
TypeElement(CD)
292. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction
Definition

This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)

ShortThis attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)
Control0..1
TypeElement(CD)
294. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)

ShortThe number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)
Control0..1
TypeElement(II)
296. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)

ShortThe legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)
Control0..1
TypeElement(CD)
298. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation
Definition

9.3.2.3

Short9.3.2.3
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
300. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
302. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
304. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
306. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
308. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
310. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
312. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
314. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
316. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
318. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
320. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
322. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
324. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
326. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
328. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
330. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
332. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
334. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
336. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
338. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME
Definition

9.3.2.4

Short9.3.2.4
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
340. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
342. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag
Definition

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

ShortThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
Control1..1
TypeElement(BL)
344. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size
Definition

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

ShortThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
Control0..1
TypeElement(CD)
346. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber
Definition

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

ShortThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
Control0..1
TypeElement(II)
348. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate
Definition

This is the date when the SME status was granted. (9.3.2.4.4)

ShortThis is the date when the SME status was granted. (9.3.2.4.4)
Control0..1
TypeElement(DT)
350. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure
Definition

9.3.2.6

Short9.3.2.6
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
352. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
354. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number
Definition

The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)

ShortThe unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)
Control0..1
TypeElement(II)
356. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType
Definition

The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)

ShortThe type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)
Control1..1
TypeElement(CD)
358. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart
Definition

The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)

ShortThe initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)
Control0..1
TypeElement(DT)
360. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd
Definition

The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)

ShortThe end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)
Control0..1
TypeElement(DT)
362. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication
Definition

9.3.2.7

Short9.3.2.7
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
364. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
366. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number
Definition

A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)

ShortA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)
Control1..1
TypeElement(II)
368. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType
Definition

The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)

ShortThe type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)
Control1..1
TypeElement(CD)
370. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate
Definition

The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)

ShortThe date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)
Control1..1
TypeElement(DT)
372. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
374. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
376. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
378. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
380. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
382. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
384. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
386. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
388. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
390. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
392. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
394. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
396. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
398. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
400. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
402. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
404. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
406. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
408. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
410. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
412. MedicinalProduct.MarketingAuthorisation.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
414. MedicinalProduct.MarketingAuthorisation.StatusReasons.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
416. MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
418. MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
420. MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
422. MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
424. MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
426. MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
428. MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
430. MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
432. MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
434. MedicinalProduct.MarketingStatus
Definition

9.3.2.8

Short9.3.2.8
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
436. MedicinalProduct.MarketingStatus.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
438. MedicinalProduct.MarketingStatus.Country
Definition

The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)

ShortThe country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)
Control1..1
TypeElement(CD)
440. MedicinalProduct.MarketingStatus.Jurisdiction
Definition

Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)

ShortWhere a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)
Control0..1
TypeElement(CD)
442. MedicinalProduct.MarketingStatus.MarketingStatus
Definition

This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)

ShortThis attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)
Control1..1
TypeElement(CD)
444. MedicinalProduct.MarketingStatus.MarketingDateStart
Definition

The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)

ShortThe date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)
Control1..1
TypeElement(DT)
446. MedicinalProduct.MarketingStatus.MarketingDateStop
Definition

The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)

ShortThe date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)
Control1..1
TypeElement(DT)
448. MedicinalProduct.MarketingStatus.RiskOfSupplyShortage
Definition

Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)

ShortIndication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)
Control0..1
TypeElement(BL)
450. MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment
Definition

Any additional comment on supply shortage. (9.3.2.8.8)

ShortAny additional comment on supply shortage. (9.3.2.8.8)
Control0..1
TypeElement(ST)
452. MedicinalProduct.MarketingStatus.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
454. MedicinalProduct.MarketingStatus.StatusReasons.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
456. MedicinalProduct.MarketingStatus.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
458. MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
460. MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
462. MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
464. MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
466. MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
468. MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
470. MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
472. MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
474. MedicinalProduct.MasterFile
Definition

9.2.2.5

Short9.2.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
476. MedicinalProduct.MasterFile.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
478. MedicinalProduct.MasterFile.FileType
Definition

This attribute is to define which kind of master file is indicated (9.2.2.5.2)

ShortThis attribute is to define which kind of master file is indicated (9.2.2.5.2)
Control1..1
TypeElement(CD)
480. MedicinalProduct.MasterFile.FileCode
Definition

This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)

ShortThis attribute is for a code to uniquely identify a master file. (9.2.2.5.3)
Control1..1
TypeElement(II)
482. MedicinalProduct.MasterFile.MasterFileHolder-Organisation
Definition

9.2.2.6

Short9.2.2.6
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
484. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
486. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
488. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
490. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
492. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
494. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
496. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
498. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
500. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
502. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
504. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
506. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
508. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
510. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
512. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
514. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
516. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
518. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
520. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
522. MedicinalProduct.MedicinalProductName
Definition

9.2.2.8

Short9.2.2.8
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
524. MedicinalProduct.MedicinalProductName.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
526. MedicinalProduct.MedicinalProductName.FullName
Definition

The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)

ShortThe full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)
Control1..1
TypeElement(ST)
528. MedicinalProduct.MedicinalProductName.InventedNamePart
Definition

The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)

ShortThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
Control0..*
TypeElement(ST)
530. MedicinalProduct.MedicinalProductName.ScientificNamePart
Definition

The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)

ShortThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
Control0..*
TypeElement(ST)
532. MedicinalProduct.MedicinalProductName.StrengthPart
Definition

The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)

ShortThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
Control0..*
TypeElement(ST)
534. MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart
Definition

The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)

ShortThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
Control0..*
TypeElement(ST)
536. MedicinalProduct.MedicinalProductName.FormulationPart
Definition

The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)

ShortThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
Control0..*
TypeElement(ST)
538. MedicinalProduct.MedicinalProductName.IntendedUsePart
Definition

The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)

ShortThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
Control0..*
TypeElement(ST)
540. MedicinalProduct.MedicinalProductName.TargetPopulationPart
Definition

The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)

ShortThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
Control0..*
TypeElement(ST)
542. MedicinalProduct.MedicinalProductName.ContainerOrPackPart
Definition

The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)

ShortThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
Control0..*
TypeElement(ST)
544. MedicinalProduct.MedicinalProductName.DevicePart
Definition

The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)

ShortThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
Control0..*
TypeElement(ST)
546. MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart
Definition

The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)

ShortThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
Control0..*
TypeElement(ST)
548. MedicinalProduct.MedicinalProductName.Time-PeriodPart
Definition

The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)

ShortThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
Control0..*
TypeElement(ST)
550. MedicinalProduct.MedicinalProductName.FlavourPart
Definition

The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)

ShortThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
Control0..*
TypeElement(ST)
552. MedicinalProduct.MedicinalProductName.DelimiterPart
Definition

A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)

ShortA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
Control0..*
TypeElement(ST)
554. MedicinalProduct.MedicinalProductName.Country-Language
Definition

9.2.2.9

Short9.2.2.9
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
556. MedicinalProduct.MedicinalProductName.Country-Language.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
558. MedicinalProduct.MedicinalProductName.Country-Language.Country
Definition

The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)

ShortThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
Control1..1
TypeElement(CD)
560. MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction
Definition

The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)

ShortThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
Control0..1
TypeElement(CD)
562. MedicinalProduct.MedicinalProductName.Country-Language.Language
Definition

The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)

ShortThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
Control1..1
TypeElement(CD)
564. MedicinalProduct.OrphanDesignation
Definition

9.2.2.3

Short9.2.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
566. MedicinalProduct.OrphanDesignation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
568. MedicinalProduct.OrphanDesignation.OrphanIndicationType
Definition

This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)

ShortThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
Control1..1
TypeElement(CD)
570. MedicinalProduct.OrphanDesignation.OrphanProcedureNumber
Definition

This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)

ShortThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
Control0..1
TypeElement(II)
572. MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus
Definition

This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)

ShortThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
Control1..1
TypeElement(CD)
574. MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate
Definition

This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)

ShortThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
Control0..1
TypeElement(DT)
576. MedicinalProduct.OrphanDesignation.OrphanDesignationNumber
Definition

This field is to indicate the orphan designation decision number. (9.2.2.3.6)

ShortThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
Control0..1
TypeElement(II)
578. MedicinalProduct.PackagedMedicinalProduct
Definition

9.6.2.2

Short9.6.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
580. MedicinalProduct.PackagedMedicinalProduct.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
582. MedicinalProduct.PackagedMedicinalProduct.PCID
Definition

This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)

ShortThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
Control1..1
TypeElement(II)
584. MedicinalProduct.PackagedMedicinalProduct.PackageDescription
Definition

A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)

ShortA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
Control1..1
TypeElement(ST)
586. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier
Definition

9.6.2.8

Short9.6.2.8
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
588. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
590. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1
Definition

The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)

ShortThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
Control1..1
TypeElement(II)
592. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2
Definition

The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)

ShortThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
Control0..1
TypeElement(II)
594. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate
Definition

This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)

ShortThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
Control1..1
TypeElement(DT)
596. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
598. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
600. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
602. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
604. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
606. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
608. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
610. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
612. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
614. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
616. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
618. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
620. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
622. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
624. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
626. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
628. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
630. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
632. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
634. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
636. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
638. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
640. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
642. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
644. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
646. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
648. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
650. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
652. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
654. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
656. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
658. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
660. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
662. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
664. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
666. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
668. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
670. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
672. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
674. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
676. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
678. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
680. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
682. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
684. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
686. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
688. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation
Definition

9.3.2.2

Short9.3.2.2
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
690. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
692. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)

ShortThe number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)
Control1..1
TypeElement(II)
694. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country
Definition

The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)

ShortThe country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)
Control1..*
TypeElement(CD)
696. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)

ShortThe legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)
Control1..1
TypeElement(CD)
698. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus
Definition

The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)

ShortThe status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)
Control1..1
TypeElement(CD)
700. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate
Definition

The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)

ShortThe date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)
Control1..1
TypeElement(DT)
702. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart
Definition

The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)

ShortThe beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)
Control1..1
TypeElement(DT)
704. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd
Definition

The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)

ShortThe end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)
Control1..1
TypeElement(DT)
706. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate
Definition

The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)

ShortThe “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)
Control0..1
TypeElement(DT)
708. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate
Definition

The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)

ShortThe end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)
Control0..1
TypeElement(DT)
710. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation
Definition

The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)

ShortThe date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)
Control0..1
TypeElement(DT)
712. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate
Definition

This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)

ShortThis is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)
Control1..1
TypeElement(DT)
714. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation
Definition

9.3.2.10

Short9.3.2.10
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
716. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
718. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country
Definition

This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)

ShortThis attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)
Control1..1
TypeElement(CD)
720. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction
Definition

This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)

ShortThis attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)
Control0..1
TypeElement(CD)
722. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)

ShortThe number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)
Control0..1
TypeElement(II)
724. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)

ShortThe legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)
Control0..1
TypeElement(CD)
726. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation
Definition

9.3.2.3

Short9.3.2.3
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
728. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
730. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
732. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
734. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
736. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
738. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
740. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
742. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
744. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
746. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
748. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
750. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
752. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
754. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
756. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
758. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
760. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
762. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
764. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
766. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME
Definition

9.3.2.4

Short9.3.2.4
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
768. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
770. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag
Definition

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

ShortThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
Control1..1
TypeElement(BL)
772. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size
Definition

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

ShortThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
Control0..1
TypeElement(CD)
774. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber
Definition

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

ShortThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
Control0..1
TypeElement(II)
776. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate
Definition

This is the date when the SME status was granted. (9.3.2.4.4)

ShortThis is the date when the SME status was granted. (9.3.2.4.4)
Control0..1
TypeElement(DT)
778. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure
Definition

9.3.2.6

Short9.3.2.6
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
780. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
782. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number
Definition

The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)

ShortThe unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)
Control0..1
TypeElement(II)
784. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType
Definition

The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)

ShortThe type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)
Control1..1
TypeElement(CD)
786. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart
Definition

The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)

ShortThe initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)
Control0..1
TypeElement(DT)
788. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd
Definition

The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)

ShortThe end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)
Control0..1
TypeElement(DT)
790. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication
Definition

9.3.2.7

Short9.3.2.7
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
792. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
794. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number
Definition

A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)

ShortA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)
Control1..1
TypeElement(II)
796. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType
Definition

The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)

ShortThe type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)
Control1..1
TypeElement(CD)
798. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate
Definition

The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)

ShortThe date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)
Control1..1
TypeElement(DT)
800. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
802. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
804. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
806. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
808. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
810. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
812. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
814. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
816. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
818. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
820. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
822. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
824. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
826. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
828. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
830. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
832. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
834. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
836. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
838. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
840. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
842. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
844. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
846. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
848. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
850. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
852. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
854. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
856. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
858. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
860. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
862. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus
Definition

9.3.2.8

Short9.3.2.8
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
864. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
866. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country
Definition

The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)

ShortThe country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)
Control1..1
TypeElement(CD)
868. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction
Definition

Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)

ShortWhere a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)
Control0..1
TypeElement(CD)
870. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus
Definition

This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)

ShortThis attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)
Control1..1
TypeElement(CD)
872. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart
Definition

The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)

ShortThe date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)
Control1..1
TypeElement(DT)
874. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop
Definition

The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)

ShortThe date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)
Control1..1
TypeElement(DT)
876. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage
Definition

Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)

ShortIndication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)
Control0..1
TypeElement(BL)
878. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment
Definition

Any additional comment on supply shortage. (9.3.2.8.8)

ShortAny additional comment on supply shortage. (9.3.2.8.8)
Control0..1
TypeElement(ST)
880. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
882. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
884. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
886. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
888. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
890. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
892. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
894. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
896. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
898. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
900. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
902. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container
Definition

9.6.2.3

Short9.6.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
904. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
906. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType
Definition

The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)

ShortThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
Control1..1
TypeElement(CD)
908. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity
Definition

The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)

ShortThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
Control1..1
TypeElement(PQ)
910. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Material
Definition

The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)

ShortThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
Control1..*
TypeElement(CD)
912. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.AlternateMaterial
Definition

The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)

ShortThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
Control0..*
TypeElement(CD)
914. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier
Definition

9.6.2.4

Short9.6.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
916. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
918. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem
Definition

The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)

ShortThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
Control1..1
TypeElement(CD)
920. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value
Definition

The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)

ShortThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
Control1..1
TypeElement(CD)
922. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
924. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
926. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeElement(CD)
928. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
TypeElement(ST)
930. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeElement(PQ)
932. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
TypeElement(ST)
934. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeElement(II)
936. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
TypeElement(ST)
938. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeElement(CD)
940. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeElement(CD)
942. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeElement(CD)
944. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier
Definition

9.6.2.15

Short9.6.2.15
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
946. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
948. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
TypeElement(ST)
950. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
TypeElement(DT)
952. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
954. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
956. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeElement(CD)
958. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
960. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
962. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature
Definition

9.6.2.14

Short9.6.2.14
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
964. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
966. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeElement(CD)
968. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeElement(CD)
970. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
972. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
974. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
976. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
978. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
980. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
982. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
984. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
986. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
988. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
990. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
992. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
994. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
996. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
998. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1000. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1002. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1004. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1006. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1008. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1010. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1012. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1014. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1016. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1018. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1020. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1022. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1024. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1026. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1028. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1030. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1032. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1034. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1036. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1038. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1040. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1042. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1044. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1046. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1048. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1050. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1052. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1054. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1056. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1058. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1060. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1062. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1064. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1066. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1068. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1070. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1072. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1074. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1076. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1078. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1080. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1082. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1084. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1086. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1088. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1090. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1092. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1094. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1096. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1098. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1100. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeElement(CD)
1102. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeElement(PQ)
1104. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeElement(CD)
1106. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem
Definition

9.6.2.20

Short9.6.2.20
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1108. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1110. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm
Definition

This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)

ShortThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
Control1..1
TypeElement(CD)
1112. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation
Definition

This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)

ShortThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
Control0..1
TypeElement(CD)
1114. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity
Definition

The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)

ShortThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
Control1..1
TypeElement(PQ)
1116. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient
Definition

9.7.2.2

Short9.7.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1118. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1120. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeElement(CD)
1122. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
1124. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1126. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1128. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1130. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1132. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1134. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1136. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1138. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1140. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1142. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1144. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1146. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1148. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1150. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1152. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1154. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1156. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1158. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1160. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1162. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1164. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1166. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1168. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1170. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1172. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1174. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1176. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1178. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1180. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1182. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1184. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1186. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1188. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1190. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1192. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1194. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1196. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1198. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1200. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1202. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1204. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1206. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1208. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1210. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1212. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1214. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1216. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1218. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1220. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeElement(CD)
1222. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeElement(CD)
1224. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeElement(CD)
1226. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1228. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1230. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
1232. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
1234. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
1236. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
1238. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1240. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1242. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
1244. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
1246. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
1248. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
1250. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
1252. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1254. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1256. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeElement(CD)
1258. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1260. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1262. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
1264. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
1266. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
1268. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
1270. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1272. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1274. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
1276. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
1278. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
1280. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
1282. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
1284. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1286. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1288. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1290. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1292. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1294. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1296. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1298. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1300. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1302. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1304. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1306. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1308. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1310. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1312. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1314. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1316. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1318. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1320. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1322. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1324. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1326. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1328. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1330. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1332. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1334. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1336. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1338. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1340. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1342. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1344. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1346. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1348. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1350. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1352. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1354. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1356. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1358. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1360. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1362. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1364. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1366. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1368. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1370. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1372. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1374. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1376. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1378. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1380. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1382. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1384. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1386. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1388. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1390. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1392. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1394. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1396. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1398. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1400. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1402. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1404. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1406. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1408. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1410. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1412. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1414. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1416. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1418. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1420. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1422. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1424. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1426. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1428. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1430. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1432. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1434. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1436. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1438. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1440. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1442. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1444. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1446. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1448. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1450. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1452. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1454. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1456. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1458. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1460. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1462. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1464. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1466. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1468. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1470. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1472. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1474. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1476. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1478. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1480. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1482. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1484. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1486. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1488. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1490. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1492. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1494. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1496. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1498. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1500. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1502. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1504. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1506. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1508. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1510. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component
Definition

9.6.2.9

Short9.6.2.9
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1512. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1514. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType
Definition

The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)

ShortThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
Control1..1
TypeElement(CD)
1516. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial
Definition

The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)

ShortThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
Control0..*
TypeElement(CD)
1518. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial
Definition

Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)

ShortAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
Control0..*
TypeElement(CD)
1520. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1522. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1524. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1526. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1528. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1530. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1532. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1534. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1536. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1538. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1540. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1542. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1544. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1546. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1548. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1550. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1552. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1554. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1556. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1558. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1560. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1562. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1564. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1566. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1568. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1570. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1572. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1574. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1576. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1578. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1580. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1582. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1584. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1586. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1588. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1590. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1592. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1594. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1596. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1598. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1600. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1602. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1604. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1606. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1608. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1610. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1612. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1614. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1616. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1618. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1620. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1622. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1624. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1626. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1628. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1630. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1632. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1634. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1636. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1638. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1640. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1642. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1644. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1646. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1648. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1650. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1652. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1654. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1656. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1658. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1660. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1662. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1664. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1666. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1668. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeElement(CD)
1670. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeElement(PQ)
1672. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeElement(CD)
1674. MedicinalProduct.PharmaceuticalProduct
Definition

9.8.2.2

Short9.8.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1676. MedicinalProduct.PharmaceuticalProduct.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1678. MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm
Definition

This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)

ShortThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
Control1..1
TypeElement(CD)
1680. MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation
Definition

The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)

ShortThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
Control0..1
TypeElement(CD)
1682. MedicinalProduct.PharmaceuticalProduct.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1684. MedicinalProduct.PharmaceuticalProduct.Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1686. MedicinalProduct.PharmaceuticalProduct.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeElement(CD)
1688. MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
TypeElement(ST)
1690. MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeElement(PQ)
1692. MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
TypeElement(ST)
1694. MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeElement(II)
1696. MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
TypeElement(ST)
1698. MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeElement(CD)
1700. MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeElement(CD)
1702. MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeElement(CD)
1704. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier
Definition

9.6.2.15

Short9.6.2.15
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1706. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1708. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
TypeElement(ST)
1710. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
TypeElement(DT)
1712. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1714. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1716. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeElement(CD)
1718. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
1720. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
1722. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature
Definition

9.6.2.14

Short9.6.2.14
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1724. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1726. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeElement(CD)
1728. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeElement(CD)
1730. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1732. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1734. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1736. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1738. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1740. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1742. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1744. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1746. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1748. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1750. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1752. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1754. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1756. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1758. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1760. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1762. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1764. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1766. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1768. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1770. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1772. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1774. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1776. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1778. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1780. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1782. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1784. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1786. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1788. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1790. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1792. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1794. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1796. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1798. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1800. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1802. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1804. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1806. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1808. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1810. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1812. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1814. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1816. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1818. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1820. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1822. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1824. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1826. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1828. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1830. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1832. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1834. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1836. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1838. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1840. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1842. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1844. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1846. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1848. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1850. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1852. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1854. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1856. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1858. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1860. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeElement(CD)
1862. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeElement(PQ)
1864. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeElement(CD)
1866. MedicinalProduct.PharmaceuticalProduct.Ingredient
Definition

9.7.2.2

Short9.7.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1868. MedicinalProduct.PharmaceuticalProduct.Ingredient.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1870. MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeElement(CD)
1872. MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
1874. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1876. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1878. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1880. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1882. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1884. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1886. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1888. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1890. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1892. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1894. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1896. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1898. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1900. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1902. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1904. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1906. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1908. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1910. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1912. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1914. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1916. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1918. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1920. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1922. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1924. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1926. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1928. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1930. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1932. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1934. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1936. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1938. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1940. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1942. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1944. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1946. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1948. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1950. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1952. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1954. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1956. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1958. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1960. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1962. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1964. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1966. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1968. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1970. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeElement(CD)
1972. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeElement(CD)
1974. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeElement(CD)
1976. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1978. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1980. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
1982. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
1984. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
1986. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
1988. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1990. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1992. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
1994. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
1996. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
1998. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
2000. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
2002. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2004. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2006. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeElement(CD)
2008. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2010. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2012. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
2014. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
2016. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
2018. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
2020. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2022. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2024. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
2026. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
2028. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
2030. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
2032. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
2034. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics
Definition

9.8.2.4

Short9.8.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2036. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2038. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem
Definition

The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)

ShortThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
Control1..1
TypeElement(CD)
2040. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value
Definition

The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)

ShortThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
Control1..1
TypeElement(CD)
2042. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status
Definition

The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)

ShortThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
Control0..1
TypeElement(CD)
2044. MedicinalProduct.PharmaceuticalProduct.PhPIDSet
Definition

9.8.2.6

Short9.8.2.6
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2046. MedicinalProduct.PharmaceuticalProduct.PhPIDSet.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2048. MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets
Definition

This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)

ShortThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
Control1..1
TypeElement(II)
2050. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration
Definition

9.8.2.3

Short9.8.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2052. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2054. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration
Definition

The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)

ShortThe route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)
Control1..1
TypeElement(CD)
2056. MedicinalProduct.ProductClassification
Definition

9.2.2.4

Short9.2.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2058. MedicinalProduct.ProductClassification.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2060. MedicinalProduct.ProductClassification.CodeSystem
Definition

The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)

ShortThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
Control1..1
TypeElement(CD)
2062. MedicinalProduct.ProductClassification.Value
Definition

The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)

ShortThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
Control1..1
TypeElement(CD)
2064. MedicinalProduct.ProductCross-Reference
Definition

9.2.2.7

Short9.2.2.7
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2066. MedicinalProduct.ProductCross-Reference.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2068. MedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference
Definition

This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)

ShortThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
Control1..1
TypeElement(II)
2070. MedicinalProduct.ProductCross-Reference.ReferencedProductType
Definition

This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)

ShortThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
Control0..1
TypeElement(CD)
2072. MedicinalProduct.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2074. MedicinalProduct.TherapeuticIndication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2076. MedicinalProduct.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
TypeElement(ST)
2078. MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeElement(CD)
2080. MedicinalProduct.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeElement(CD)
2082. MedicinalProduct.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeElement(CD)
2084. MedicinalProduct.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeElement(CD)
2086. MedicinalProduct.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeElement(PQ)
2088. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2090. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2092. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeElement(CD)
2094. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeElement(CD)
2096. MedicinalProduct.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2098. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2100. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
2102. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
2104. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
2106. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
2108. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
2110. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
2112. MedicinalProduct.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2114. MedicinalProduct.TherapeuticIndication.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2116. MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
TypeElement(ST)
2118. MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeElement(CD)
2120. MedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeElement(CD)
2122. MedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeElement(CD)
2124. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2126. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2128. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
2130. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
2132. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
2134. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
2136. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
2138. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
2140. MedicinalProduct.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2142. MedicinalProduct.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2144. MedicinalProduct.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
TypeElement(ST)
2146. MedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeElement(CD)
2148. MedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeElement(CD)
2150. MedicinalProduct.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeElement(CD)
2152. MedicinalProduct.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2154. MedicinalProduct.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2156. MedicinalProduct.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
2158. MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
2160. MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
2162. MedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
2164. MedicinalProduct.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
2166. MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)

Guidance on how to interpret the contents of this table can be found here

0. MedicinalProduct
Definition

ISO 11615 Authorised Medicinal Product

Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. MedicinalProduct.MPID
Definition

This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)

ShortThis is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)
Control1..1
TypeElement(II)
4. MedicinalProduct.CombinedPharmaceuticalDoseForm
Definition

The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)

ShortThe combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)
Control0..1
TypeElement(CD)
6. MedicinalProduct.AdditionalMonitoringIndicator
Definition

If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)

ShortIf the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)
Control0..1
TypeElement(CD)
8. MedicinalProduct.SpecialMeasures
Definition

If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)

ShortIf the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)
Control0..*
TypeElement(ST)
10. MedicinalProduct.PaediatricUseIndicator
Definition

This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)

ShortThis is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)
Control0..1
TypeElement(CD)
12. MedicinalProduct.OrphanDesignationStatus
Definition

The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)

ShortThe description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)
Control0..1
TypeElement(CD)
14. MedicinalProduct.AttachedDocument
Definition

9.2.2.11

Short9.2.2.11
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. MedicinalProduct.AttachedDocument.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
18. MedicinalProduct.AttachedDocument.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.AttachedDocument.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
20. MedicinalProduct.AttachedDocument.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
22. MedicinalProduct.AttachedDocument.Identifier
Definition

The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)

ShortThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
Control1..1
TypeElement(II)
24. MedicinalProduct.AttachedDocument.EffectiveDate
Definition

The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)

ShortThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
Control1..1
TypeElement(DT)
26. MedicinalProduct.AttachedDocument.Type
Definition

The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)

ShortThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
Control1..1
TypeElement(CD)
28. MedicinalProduct.AttachedDocument.Content
Definition

The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)

ShortThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
Control1..1
TypeElement(ED)
30. MedicinalProduct.AttachedDocument.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
Control0..1
TypeElement(CD)
32. MedicinalProduct.AttachedDocument.MediaType
Definition

This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)

ShortThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
Control0..1
TypeElement(CD)
34. MedicinalProduct.AttachedDocument.VersionNumber
Definition

This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)

ShortThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
Control0..1
TypeElement(ST)
36. MedicinalProduct.AttachedDocument.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)

ShortThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
Control0..1
TypeElement(II)
38. MedicinalProduct.Contraindication
Definition

9.9.2.3

Short9.9.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. MedicinalProduct.Contraindication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
42. MedicinalProduct.Contraindication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Contraindication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
44. MedicinalProduct.Contraindication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
46. MedicinalProduct.Contraindication.ContraindicationsText
Definition

The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)

ShortThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
Control1..1
TypeElement(ST)
48. MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)

ShortThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
Control0..1
TypeElement(CD)
50. MedicinalProduct.Contraindication.DiseaseStatus
Definition

The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)

ShortThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
Control0..1
TypeElement(CD)
52. MedicinalProduct.Contraindication.Comorbidity
Definition

The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)

ShortThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
Control0..*
TypeElement(CD)
54. MedicinalProduct.Contraindication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. MedicinalProduct.Contraindication.OtherTherapySpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
58. MedicinalProduct.Contraindication.OtherTherapySpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Contraindication.OtherTherapySpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
60. MedicinalProduct.Contraindication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
62. MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeElement(CD)
64. MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeElement(CD)
66. MedicinalProduct.Contraindication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. MedicinalProduct.Contraindication.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
70. MedicinalProduct.Contraindication.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Contraindication.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
72. MedicinalProduct.Contraindication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
74. MedicinalProduct.Contraindication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
76. MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
78. MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
80. MedicinalProduct.Contraindication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
82. MedicinalProduct.Contraindication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
84. MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
86. MedicinalProduct.Contraindication.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. MedicinalProduct.Contraindication.TherapeuticIndication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
90. MedicinalProduct.Contraindication.TherapeuticIndication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Contraindication.TherapeuticIndication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
92. MedicinalProduct.Contraindication.TherapeuticIndication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
94. MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
TypeElement(ST)
96. MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeElement(CD)
98. MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeElement(CD)
100. MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeElement(CD)
102. MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeElement(CD)
104. MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeElement(PQ)
106. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
110. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
112. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
114. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeElement(CD)
116. MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeElement(CD)
118. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
122. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
124. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
126. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
128. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
130. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
132. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
134. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
136. MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
138. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
140. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
142. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
144. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
146. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
TypeElement(ST)
148. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeElement(CD)
150. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeElement(CD)
152. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeElement(CD)
154. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
156. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
158. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
160. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
162. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
164. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
166. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
168. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
170. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
172. MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
174. MedicinalProduct.Header
Definition

9.2.2.10

Short9.2.2.10
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
176. MedicinalProduct.Header.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
178. MedicinalProduct.Header.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Header.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
180. MedicinalProduct.Header.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
182. MedicinalProduct.Header.Identifier
Definition

This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)

ShortThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
Control1..1
TypeElement(II)
184. MedicinalProduct.Header.EffectiveDate
Definition

The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)

ShortThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
Control1..1
TypeElement(DT)
186. MedicinalProduct.Header.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
Control0..1
TypeElement(CD)
188. MedicinalProduct.Header.VersionNumber
Definition

This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)

ShortThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
Control0..1
TypeElement(ST)
190. MedicinalProduct.Header.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)

ShortThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
Control0..1
TypeElement(II)
192. MedicinalProduct.Interactions
Definition

9.9.2.7

Short9.9.2.7
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
194. MedicinalProduct.Interactions.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
196. MedicinalProduct.Interactions.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Interactions.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
198. MedicinalProduct.Interactions.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
200. MedicinalProduct.Interactions.InteractionsText
Definition

The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)

ShortThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
Control1..1
TypeElement(ST)
202. MedicinalProduct.Interactions.Interactant
Definition

This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)

ShortThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
Control0..*
TypeElement(CD)
204. MedicinalProduct.Interactions.InteractionsType
Definition

The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)

ShortThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
Control0..1
TypeElement(CD)
206. MedicinalProduct.Interactions.InteractionsEffect
Definition

The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)

ShortThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
Control0..1
TypeElement(CD)
208. MedicinalProduct.Interactions.InteractionsIncidence
Definition

The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)

ShortThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
Control0..1
TypeElement(CD)
210. MedicinalProduct.Interactions.ManagementActions
Definition

The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)

ShortThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
Control0..1
TypeElement(CD)
212. MedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
214. MedicinalProduct.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
216. MedicinalProduct.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
218. MedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
220. MedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
222. MedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
224. MedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
226. MedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
228. MedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
230. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
232. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
234. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
236. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
238. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
240. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
242. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
244. MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
246. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
248. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
250. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
252. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
254. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
256. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
258. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
260. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
262. MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
264. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
266. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
268. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
270. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
272. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
274. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
276. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
278. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
280. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
282. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
284. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
286. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
288. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
290. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
292. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
294. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
296. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
298. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
300. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
302. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
304. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
306. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
308. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
310. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
312. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
314. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
316. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
318. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
320. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
322. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
324. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
326. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
328. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
330. MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
332. MedicinalProduct.MarketingAuthorisation
Definition

9.3.2.2

Short9.3.2.2
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
334. MedicinalProduct.MarketingAuthorisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
336. MedicinalProduct.MarketingAuthorisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
338. MedicinalProduct.MarketingAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
340. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)

ShortThe number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)
Control1..1
TypeElement(II)
342. MedicinalProduct.MarketingAuthorisation.Country
Definition

The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)

ShortThe country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)
Control1..*
TypeElement(CD)
344. MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)

ShortThe legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)
Control1..1
TypeElement(CD)
346. MedicinalProduct.MarketingAuthorisation.AuthorisationStatus
Definition

The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)

ShortThe status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)
Control1..1
TypeElement(CD)
348. MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate
Definition

The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)

ShortThe date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)
Control1..1
TypeElement(DT)
350. MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart
Definition

The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)

ShortThe beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)
Control1..1
TypeElement(DT)
352. MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd
Definition

The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)

ShortThe end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)
Control1..1
TypeElement(DT)
354. MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate
Definition

The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)

ShortThe “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)
Control0..1
TypeElement(DT)
356. MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate
Definition

The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)

ShortThe end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)
Control0..1
TypeElement(DT)
358. MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation
Definition

The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)

ShortThe date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)
Control0..1
TypeElement(DT)
360. MedicinalProduct.MarketingAuthorisation.InternationalBirthDate
Definition

This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)

ShortThis is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)
Control1..1
TypeElement(DT)
362. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation
Definition

9.3.2.10

Short9.3.2.10
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
364. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
366. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
368. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
370. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country
Definition

This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)

ShortThis attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)
Control1..1
TypeElement(CD)
372. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction
Definition

This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)

ShortThis attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)
Control0..1
TypeElement(CD)
374. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)

ShortThe number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)
Control0..1
TypeElement(II)
376. MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)

ShortThe legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)
Control0..1
TypeElement(CD)
378. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation
Definition

9.3.2.3

Short9.3.2.3
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
380. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
382. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
384. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
386. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
388. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
390. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
392. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
394. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
396. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
398. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
400. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
402. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
404. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
406. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
408. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
410. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
412. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
414. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
416. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
418. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
420. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
422. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
424. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
426. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
428. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
430. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME
Definition

9.3.2.4

Short9.3.2.4
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
432. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
434. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
436. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
438. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag
Definition

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

ShortThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
Control1..1
TypeElement(BL)
440. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size
Definition

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

ShortThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
Control0..1
TypeElement(CD)
442. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber
Definition

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

ShortThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
Control0..1
TypeElement(II)
444. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate
Definition

This is the date when the SME status was granted. (9.3.2.4.4)

ShortThis is the date when the SME status was granted. (9.3.2.4.4)
Control0..1
TypeElement(DT)
446. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure
Definition

9.3.2.6

Short9.3.2.6
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
448. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
450. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
452. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
454. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number
Definition

The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)

ShortThe unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)
Control0..1
TypeElement(II)
456. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType
Definition

The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)

ShortThe type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)
Control1..1
TypeElement(CD)
458. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart
Definition

The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)

ShortThe initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)
Control0..1
TypeElement(DT)
460. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd
Definition

The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)

ShortThe end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)
Control0..1
TypeElement(DT)
462. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication
Definition

9.3.2.7

Short9.3.2.7
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
464. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
466. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
468. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
470. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number
Definition

A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)

ShortA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)
Control1..1
TypeElement(II)
472. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType
Definition

The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)

ShortThe type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)
Control1..1
TypeElement(CD)
474. MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate
Definition

The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)

ShortThe date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)
Control1..1
TypeElement(DT)
476. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
478. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
480. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
482. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
484. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
486. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
488. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
490. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
492. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
494. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
496. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
498. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
500. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
502. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
504. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
506. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
508. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
510. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
512. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
514. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
516. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
518. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
520. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
522. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
524. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
526. MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
528. MedicinalProduct.MarketingAuthorisation.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
530. MedicinalProduct.MarketingAuthorisation.StatusReasons.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
532. MedicinalProduct.MarketingAuthorisation.StatusReasons.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingAuthorisation.StatusReasons.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
534. MedicinalProduct.MarketingAuthorisation.StatusReasons.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
536. MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
538. MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
540. MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
542. MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
544. MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
546. MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
548. MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
550. MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
552. MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
554. MedicinalProduct.MarketingStatus
Definition

9.3.2.8

Short9.3.2.8
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
556. MedicinalProduct.MarketingStatus.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
558. MedicinalProduct.MarketingStatus.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingStatus.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
560. MedicinalProduct.MarketingStatus.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
562. MedicinalProduct.MarketingStatus.Country
Definition

The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)

ShortThe country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)
Control1..1
TypeElement(CD)
564. MedicinalProduct.MarketingStatus.Jurisdiction
Definition

Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)

ShortWhere a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)
Control0..1
TypeElement(CD)
566. MedicinalProduct.MarketingStatus.MarketingStatus
Definition

This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)

ShortThis attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)
Control1..1
TypeElement(CD)
568. MedicinalProduct.MarketingStatus.MarketingDateStart
Definition

The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)

ShortThe date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)
Control1..1
TypeElement(DT)
570. MedicinalProduct.MarketingStatus.MarketingDateStop
Definition

The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)

ShortThe date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)
Control1..1
TypeElement(DT)
572. MedicinalProduct.MarketingStatus.RiskOfSupplyShortage
Definition

Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)

ShortIndication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)
Control0..1
TypeElement(BL)
574. MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment
Definition

Any additional comment on supply shortage. (9.3.2.8.8)

ShortAny additional comment on supply shortage. (9.3.2.8.8)
Control0..1
TypeElement(ST)
576. MedicinalProduct.MarketingStatus.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
578. MedicinalProduct.MarketingStatus.StatusReasons.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
580. MedicinalProduct.MarketingStatus.StatusReasons.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MarketingStatus.StatusReasons.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
582. MedicinalProduct.MarketingStatus.StatusReasons.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
584. MedicinalProduct.MarketingStatus.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
586. MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
588. MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
590. MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
592. MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
594. MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
596. MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
598. MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
600. MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
602. MedicinalProduct.MasterFile
Definition

9.2.2.5

Short9.2.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
604. MedicinalProduct.MasterFile.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
606. MedicinalProduct.MasterFile.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MasterFile.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
608. MedicinalProduct.MasterFile.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
610. MedicinalProduct.MasterFile.FileType
Definition

This attribute is to define which kind of master file is indicated (9.2.2.5.2)

ShortThis attribute is to define which kind of master file is indicated (9.2.2.5.2)
Control1..1
TypeElement(CD)
612. MedicinalProduct.MasterFile.FileCode
Definition

This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)

ShortThis attribute is for a code to uniquely identify a master file. (9.2.2.5.3)
Control1..1
TypeElement(II)
614. MedicinalProduct.MasterFile.MasterFileHolder-Organisation
Definition

9.2.2.6

Short9.2.2.6
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
616. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
618. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MasterFile.MasterFileHolder_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
620. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
622. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
624. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
626. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
628. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
630. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
632. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
634. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
636. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
638. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
640. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
642. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
644. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
646. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
648. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
650. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
652. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
654. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
656. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
658. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
660. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
662. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
664. MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
666. MedicinalProduct.MedicinalProductName
Definition

9.2.2.8

Short9.2.2.8
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
668. MedicinalProduct.MedicinalProductName.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
670. MedicinalProduct.MedicinalProductName.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MedicinalProductName.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
672. MedicinalProduct.MedicinalProductName.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
674. MedicinalProduct.MedicinalProductName.FullName
Definition

The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)

ShortThe full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)
Control1..1
TypeElement(ST)
676. MedicinalProduct.MedicinalProductName.InventedNamePart
Definition

The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)

ShortThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
Control0..*
TypeElement(ST)
678. MedicinalProduct.MedicinalProductName.ScientificNamePart
Definition

The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)

ShortThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
Control0..*
TypeElement(ST)
680. MedicinalProduct.MedicinalProductName.StrengthPart
Definition

The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)

ShortThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
Control0..*
TypeElement(ST)
682. MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart
Definition

The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)

ShortThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
Control0..*
TypeElement(ST)
684. MedicinalProduct.MedicinalProductName.FormulationPart
Definition

The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)

ShortThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
Control0..*
TypeElement(ST)
686. MedicinalProduct.MedicinalProductName.IntendedUsePart
Definition

The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)

ShortThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
Control0..*
TypeElement(ST)
688. MedicinalProduct.MedicinalProductName.TargetPopulationPart
Definition

The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)

ShortThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
Control0..*
TypeElement(ST)
690. MedicinalProduct.MedicinalProductName.ContainerOrPackPart
Definition

The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)

ShortThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
Control0..*
TypeElement(ST)
692. MedicinalProduct.MedicinalProductName.DevicePart
Definition

The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)

ShortThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
Control0..*
TypeElement(ST)
694. MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart
Definition

The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)

ShortThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
Control0..*
TypeElement(ST)
696. MedicinalProduct.MedicinalProductName.Time-PeriodPart
Definition

The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)

ShortThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
Control0..*
TypeElement(ST)
698. MedicinalProduct.MedicinalProductName.FlavourPart
Definition

The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)

ShortThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
Control0..*
TypeElement(ST)
700. MedicinalProduct.MedicinalProductName.DelimiterPart
Definition

A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)

ShortA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
Control0..*
TypeElement(ST)
702. MedicinalProduct.MedicinalProductName.Country-Language
Definition

9.2.2.9

Short9.2.2.9
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
704. MedicinalProduct.MedicinalProductName.Country-Language.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
706. MedicinalProduct.MedicinalProductName.Country-Language.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.MedicinalProductName.Country-Language.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
708. MedicinalProduct.MedicinalProductName.Country-Language.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
710. MedicinalProduct.MedicinalProductName.Country-Language.Country
Definition

The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)

ShortThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
Control1..1
TypeElement(CD)
712. MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction
Definition

The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)

ShortThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
Control0..1
TypeElement(CD)
714. MedicinalProduct.MedicinalProductName.Country-Language.Language
Definition

The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)

ShortThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
Control1..1
TypeElement(CD)
716. MedicinalProduct.OrphanDesignation
Definition

9.2.2.3

Short9.2.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
718. MedicinalProduct.OrphanDesignation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
720. MedicinalProduct.OrphanDesignation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.OrphanDesignation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
722. MedicinalProduct.OrphanDesignation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
724. MedicinalProduct.OrphanDesignation.OrphanIndicationType
Definition

This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)

ShortThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
Control1..1
TypeElement(CD)
726. MedicinalProduct.OrphanDesignation.OrphanProcedureNumber
Definition

This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)

ShortThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
Control0..1
TypeElement(II)
728. MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus
Definition

This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)

ShortThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
Control1..1
TypeElement(CD)
730. MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate
Definition

This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)

ShortThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
Control0..1
TypeElement(DT)
732. MedicinalProduct.OrphanDesignation.OrphanDesignationNumber
Definition

This field is to indicate the orphan designation decision number. (9.2.2.3.6)

ShortThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
Control0..1
TypeElement(II)
734. MedicinalProduct.PackagedMedicinalProduct
Definition

9.6.2.2

Short9.6.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
736. MedicinalProduct.PackagedMedicinalProduct.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
738. MedicinalProduct.PackagedMedicinalProduct.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
740. MedicinalProduct.PackagedMedicinalProduct.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
742. MedicinalProduct.PackagedMedicinalProduct.PCID
Definition

This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)

ShortThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
Control1..1
TypeElement(II)
744. MedicinalProduct.PackagedMedicinalProduct.PackageDescription
Definition

A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)

ShortA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
Control1..1
TypeElement(ST)
746. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier
Definition

9.6.2.8

Short9.6.2.8
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
748. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
750. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
752. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
754. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1
Definition

The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)

ShortThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
Control1..1
TypeElement(II)
756. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2
Definition

The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)

ShortThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
Control0..1
TypeElement(II)
758. MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate
Definition

This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)

ShortThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
Control1..1
TypeElement(DT)
760. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
762. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
764. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
766. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
768. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
770. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
772. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
774. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
776. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
778. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
780. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
782. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
784. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
786. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
788. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
790. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
792. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
794. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
796. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
798. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
800. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
802. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
804. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
806. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
808. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
810. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
812. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
814. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
816. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
818. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
820. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
822. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
824. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
826. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
828. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
830. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
832. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
834. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
836. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
838. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
840. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
842. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
844. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
846. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
848. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
850. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
852. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
854. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
856. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
858. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
860. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
862. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
864. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
866. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
868. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
870. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
872. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
874. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
876. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
878. MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
880. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation
Definition

9.3.2.2

Short9.3.2.2
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
882. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
884. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
886. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
888. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)

ShortThe number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)
Control1..1
TypeElement(II)
890. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country
Definition

The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)

ShortThe country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)
Control1..*
TypeElement(CD)
892. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)

ShortThe legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)
Control1..1
TypeElement(CD)
894. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus
Definition

The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)

ShortThe status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)
Control1..1
TypeElement(CD)
896. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate
Definition

The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)

ShortThe date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)
Control1..1
TypeElement(DT)
898. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart
Definition

The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)

ShortThe beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)
Control1..1
TypeElement(DT)
900. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd
Definition

The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)

ShortThe end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)
Control1..1
TypeElement(DT)
902. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate
Definition

The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)

ShortThe “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)
Control0..1
TypeElement(DT)
904. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate
Definition

The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)

ShortThe end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)
Control0..1
TypeElement(DT)
906. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation
Definition

The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)

ShortThe date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)
Control0..1
TypeElement(DT)
908. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate
Definition

This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)

ShortThis is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)
Control1..1
TypeElement(DT)
910. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation
Definition

9.3.2.10

Short9.3.2.10
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
912. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
914. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
916. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
918. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country
Definition

This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)

ShortThis attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)
Control1..1
TypeElement(CD)
920. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction
Definition

This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)

ShortThis attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)
Control0..1
TypeElement(CD)
922. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber
Definition

The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)

ShortThe number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)
Control0..1
TypeElement(II)
924. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply
Definition

The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)

ShortThe legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)
Control0..1
TypeElement(CD)
926. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation
Definition

9.3.2.3

Short9.3.2.3
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
928. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
930. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
932. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
934. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
936. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
938. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
940. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
942. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
944. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
946. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
948. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
950. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
952. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
954. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
956. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
958. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
960. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
962. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
964. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
966. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
968. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
970. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
972. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
974. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
976. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
978. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME
Definition

9.3.2.4

Short9.3.2.4
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
980. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
982. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
984. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
986. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag
Definition

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

ShortThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
Control1..1
TypeElement(BL)
988. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size
Definition

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

ShortThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
Control0..1
TypeElement(CD)
990. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber
Definition

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

ShortThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
Control0..1
TypeElement(II)
992. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate
Definition

This is the date when the SME status was granted. (9.3.2.4.4)

ShortThis is the date when the SME status was granted. (9.3.2.4.4)
Control0..1
TypeElement(DT)
994. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure
Definition

9.3.2.6

Short9.3.2.6
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
996. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
998. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1000. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1002. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number
Definition

The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)

ShortThe unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)
Control0..1
TypeElement(II)
1004. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType
Definition

The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)

ShortThe type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)
Control1..1
TypeElement(CD)
1006. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart
Definition

The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)

ShortThe initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)
Control0..1
TypeElement(DT)
1008. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd
Definition

The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)

ShortThe end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)
Control0..1
TypeElement(DT)
1010. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication
Definition

9.3.2.7

Short9.3.2.7
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1012. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1014. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1016. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1018. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number
Definition

A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)

ShortA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)
Control1..1
TypeElement(II)
1020. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType
Definition

The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)

ShortThe type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)
Control1..1
TypeElement(CD)
1022. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate
Definition

The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)

ShortThe date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)
Control1..1
TypeElement(DT)
1024. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control1..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1026. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1028. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1030. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1032. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1034. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1036. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1038. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1040. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1042. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1044. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1046. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1048. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1050. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1052. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1054. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1056. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1058. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1060. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1062. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1064. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1066. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1068. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1070. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1072. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1074. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1076. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1078. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1080. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1082. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1084. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
1086. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
1088. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
1090. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
1092. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
1094. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
1096. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
1098. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
1100. MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
1102. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus
Definition

9.3.2.8

Short9.3.2.8
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1104. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1106. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1108. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1110. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country
Definition

The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)

ShortThe country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)
Control1..1
TypeElement(CD)
1112. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction
Definition

Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)

ShortWhere a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)
Control0..1
TypeElement(CD)
1114. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus
Definition

This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)

ShortThis attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)
Control1..1
TypeElement(CD)
1116. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart
Definition

The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)

ShortThe date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)
Control1..1
TypeElement(DT)
1118. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop
Definition

The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)

ShortThe date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)
Control1..1
TypeElement(DT)
1120. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage
Definition

Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)

ShortIndication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)
Control0..1
TypeElement(BL)
1122. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment
Definition

Any additional comment on supply shortage. (9.3.2.8.8)

ShortAny additional comment on supply shortage. (9.3.2.8.8)
Control0..1
TypeElement(ST)
1124. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons
Definition

9.3.2.9

Short9.3.2.9
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1126. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1128. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1130. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1132. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason
Definition

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

ShortThe reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)
Control0..1
TypeElement(CD)
1134. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment
Definition

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

ShortAdditional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)
Control0..1
TypeElement(ST)
1136. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds
Definition

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

ShortThe legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)
Control0..1
TypeElement(CD)
1138. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment
Definition

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

ShortAny additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)
Control0..1
TypeElement(ST)
1140. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate
Definition

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

ShortThe date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)
Control0..1
TypeElement(DT)
1142. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore
Definition

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

ShortThe condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)
Control0..1
TypeElement(CD)
1144. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment
Definition

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

ShortAdditional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)
Control0..1
TypeElement(ST)
1146. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType
Definition

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

ShortThe organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)
Control0..1
TypeElement(CD)
1148. MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken
Definition

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

ShortThe geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)
Control0..1
TypeElement(CD)
1150. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container
Definition

9.6.2.3

Short9.6.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1152. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1154. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1156. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1158. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType
Definition

The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)

ShortThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
Control1..1
TypeElement(CD)
1160. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity
Definition

The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)

ShortThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
Control1..1
TypeElement(PQ)
1162. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Material
Definition

The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)

ShortThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
Control1..*
TypeElement(CD)
1164. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.AlternateMaterial
Definition

The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)

ShortThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
Control0..*
TypeElement(CD)
1166. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier
Definition

9.6.2.4

Short9.6.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1168. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1170. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1172. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1174. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem
Definition

The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)

ShortThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
Control1..1
TypeElement(CD)
1176. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value
Definition

The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)

ShortThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
Control1..1
TypeElement(CD)
1178. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1180. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1182. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1184. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1186. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeElement(CD)
1188. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
TypeElement(ST)
1190. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeElement(PQ)
1192. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
TypeElement(ST)
1194. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeElement(II)
1196. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
TypeElement(ST)
1198. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeElement(CD)
1200. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeElement(CD)
1202. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeElement(CD)
1204. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier
Definition

9.6.2.15

Short9.6.2.15
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1206. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1208. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1210. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1212. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
TypeElement(ST)
1214. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
TypeElement(DT)
1216. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1218. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1220. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1222. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1224. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeElement(CD)
1226. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
1228. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
1230. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature
Definition

9.6.2.14

Short9.6.2.14
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1232. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1234. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1236. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1238. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeElement(CD)
1240. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeElement(CD)
1242. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1244. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1246. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1248. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1250. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1252. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1254. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1256. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1258. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1260. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1262. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1264. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1266. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1268. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1270. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1272. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1274. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1276. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1278. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1280. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1282. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1284. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1286. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1288. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1290. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1292. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1294. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1296. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1298. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1300. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1302. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1304. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1306. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1308. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1310. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1312. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1314. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1316. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1318. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1320. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1322. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1324. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1326. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1328. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1330. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1332. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1334. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1336. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1338. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1340. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1342. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1344. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1346. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1348. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1350. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1352. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1354. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1356. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1358. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1360. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1362. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1364. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1366. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1368. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1370. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1372. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1374. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1376. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1378. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1380. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1382. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1384. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1386. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1388. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1390. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1392. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1394. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1396. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1398. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1400. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1402. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1404. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1406. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1408. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1410. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1412. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeElement(CD)
1414. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeElement(PQ)
1416. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeElement(CD)
1418. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem
Definition

9.6.2.20

Short9.6.2.20
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1420. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1422. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1424. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1426. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm
Definition

This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)

ShortThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
Control1..1
TypeElement(CD)
1428. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation
Definition

This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)

ShortThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
Control0..1
TypeElement(CD)
1430. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity
Definition

The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)

ShortThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
Control1..1
TypeElement(PQ)
1432. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient
Definition

9.7.2.2

Short9.7.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1434. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1436. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1438. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1440. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeElement(CD)
1442. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
1444. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1446. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1448. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1450. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1452. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1454. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1456. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1458. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1460. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1462. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1464. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1466. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1468. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1470. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1472. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1474. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1476. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1478. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1480. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1482. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1484. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1486. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1488. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1490. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1492. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1494. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1496. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1498. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1500. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1502. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1504. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1506. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1508. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1510. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1512. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1514. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1516. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1518. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1520. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1522. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1524. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1526. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1528. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1530. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1532. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1534. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1536. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1538. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1540. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1542. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1544. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1546. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1548. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1550. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1552. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1554. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1556. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1558. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1560. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1562. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1564. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1566. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1568. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1570. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1572. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeElement(CD)
1574. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeElement(CD)
1576. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeElement(CD)
1578. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1580. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1582. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1584. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1586. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
1588. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
1590. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
1592. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
1594. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1596. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1598. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1600. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1602. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
1604. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
1606. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
1608. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
1610. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
1612. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1614. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1616. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1618. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1620. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeElement(CD)
1622. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1624. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1626. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1628. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1630. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
1632. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
1634. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
1636. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
1638. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1640. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1642. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1644. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1646. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
1648. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
1650. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
1652. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
1654. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
1656. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1658. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1660. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1662. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1664. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1666. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1668. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1670. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1672. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1674. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1676. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1678. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1680. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1682. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1684. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1686. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1688. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1690. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1692. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1694. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1696. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1698. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1700. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1702. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1704. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1706. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1708. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1710. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1712. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1714. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1716. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1718. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1720. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1722. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1724. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1726. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1728. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1730. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1732. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1734. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1736. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1738. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1740. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1742. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1744. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1746. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1748. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1750. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1752. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1754. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1756. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1758. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1760. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1762. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1764. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1766. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1768. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1770. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1772. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1774. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1776. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1778. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1780. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1782. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1784. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1786. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1788. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1790. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1792. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1794. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1796. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
1798. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
1800. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
1802. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
1804. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
1806. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
1808. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
1810. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
1812. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
1814. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
1816. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
1818. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1820. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1822. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1824. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1826. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1828. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1830. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1832. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1834. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1836. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1838. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1840. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1842. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1844. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1846. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1848. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1850. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1852. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1854. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1856. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1858. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1860. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1862. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1864. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1866. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1868. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1870. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1872. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1874. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1876. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1878. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
1880. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
1882. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
1884. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
1886. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1888. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1890. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1892. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1894. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1896. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1898. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1900. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1902. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1904. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1906. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1908. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1910. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1912. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1914. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1916. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1918. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1920. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1922. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1924. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1926. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1928. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
1930. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
1932. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
1934. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
1936. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
1938. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1940. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1942. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1944. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1946. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
1948. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
1950. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component
Definition

9.6.2.9

Short9.6.2.9
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1952. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1954. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1956. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1958. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType
Definition

The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)

ShortThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
Control1..1
TypeElement(CD)
1960. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial
Definition

The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)

ShortThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
Control0..*
TypeElement(CD)
1962. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial
Definition

Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)

ShortAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
Control0..*
TypeElement(CD)
1964. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1966. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1968. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1970. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1972. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
1974. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
1976. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
1978. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
1980. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
1982. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1984. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1986. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1988. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1990. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
1992. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
1994. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
1996. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
1998. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2000. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2002. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2004. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2006. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
2008. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
2010. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
2012. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
2014. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
2016. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2018. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2020. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2022. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2024. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
2026. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
2028. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
2030. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
2032. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2034. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2036. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2038. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2040. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
2042. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
2044. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
2046. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
2048. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
2050. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2052. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2054. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2056. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2058. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
2060. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
2062. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
2064. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
2066. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2068. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2070. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2072. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2074. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
2076. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
2078. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
2080. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
2082. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
2084. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2086. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2088. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2090. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2092. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
2094. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
2096. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
2098. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
2100. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
2102. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
2104. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
2106. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
2108. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
2110. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
2112. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
2114. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2116. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2118. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2120. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2122. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
2124. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
2126. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
2128. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
2130. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
2132. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
2134. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
2136. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
2138. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
2140. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
2142. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
2144. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2146. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2148. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2150. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2152. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeElement(CD)
2154. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeElement(PQ)
2156. MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeElement(CD)
2158. MedicinalProduct.PharmaceuticalProduct
Definition

9.8.2.2

Short9.8.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2160. MedicinalProduct.PharmaceuticalProduct.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2162. MedicinalProduct.PharmaceuticalProduct.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2164. MedicinalProduct.PharmaceuticalProduct.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2166. MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm
Definition

This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)

ShortThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
Control1..1
TypeElement(CD)
2168. MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation
Definition

The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)

ShortThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
Control0..1
TypeElement(CD)
2170. MedicinalProduct.PharmaceuticalProduct.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2172. MedicinalProduct.PharmaceuticalProduct.Device.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2174. MedicinalProduct.PharmaceuticalProduct.Device.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2176. MedicinalProduct.PharmaceuticalProduct.Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2178. MedicinalProduct.PharmaceuticalProduct.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeElement(CD)
2180. MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
TypeElement(ST)
2182. MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeElement(PQ)
2184. MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
TypeElement(ST)
2186. MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeElement(II)
2188. MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
TypeElement(ST)
2190. MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeElement(CD)
2192. MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeElement(CD)
2194. MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeElement(CD)
2196. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier
Definition

9.6.2.15

Short9.6.2.15
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2198. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2200. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2202. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2204. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
TypeElement(ST)
2206. MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
TypeElement(DT)
2208. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2210. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2212. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2214. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2216. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeElement(CD)
2218. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
2220. MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
2222. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature
Definition

9.6.2.14

Short9.6.2.14
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2224. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2226. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2228. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2230. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeElement(CD)
2232. MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeElement(CD)
2234. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2236. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2238. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2240. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2242. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
2244. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
2246. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
2248. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
2250. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
2252. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2254. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2256. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2258. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2260. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
2262. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
2264. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
2266. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
2268. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2270. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2272. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2274. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2276. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
2278. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
2280. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
2282. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
2284. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
2286. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2288. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2290. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2292. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2294. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
2296. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
2298. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
2300. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
2302. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2304. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2306. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2308. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2310. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
2312. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
2314. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
2316. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
2318. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
2320. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2322. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2324. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2326. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2328. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
2330. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
2332. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
2334. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
2336. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2338. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2340. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2342. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2344. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
2346. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
2348. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
2350. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
2352. MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
2354. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2356. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2358. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2360. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2362. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeElement(CD)
2364. MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeElement(CD)
2366. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics
Definition

9.6.2.21

Short9.6.2.21
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2368. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2370. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2372. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2374. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeElement(PQ)
2376. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeElement(PQ)
2378. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeElement(PQ)
2380. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeElement(PQ)
2382. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeElement(PQ)
2384. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeElement(PQ)
2386. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
TypeElement(ST)
2388. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
TypeElement(ST)
2390. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
TypeElement(ST)
2392. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
TypeElement(ED)
2394. MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeElement(CD)
2396. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2398. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2400. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2402. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2404. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeElement(CD)
2406. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeElement(PQ)
2408. MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeElement(CD)
2410. MedicinalProduct.PharmaceuticalProduct.Ingredient
Definition

9.7.2.2

Short9.7.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2412. MedicinalProduct.PharmaceuticalProduct.Ingredient.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2414. MedicinalProduct.PharmaceuticalProduct.Ingredient.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2416. MedicinalProduct.PharmaceuticalProduct.Ingredient.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2418. MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeElement(CD)
2420. MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
2422. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2424. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2426. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2428. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2430. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
2432. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
2434. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
2436. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
2438. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
2440. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2442. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2444. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2446. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2448. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
2450. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
2452. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
2454. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
2456. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2458. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2460. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2462. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2464. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
2466. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
2468. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
2470. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
2472. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
2474. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2476. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2478. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2480. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2482. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeElement(CD)
2484. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeElement(II)
2486. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
TypeElement(DT)
2488. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeElement(CD)
2490. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2492. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2494. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2496. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2498. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeElement(II)
2500. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
TypeElement(ST)
2502. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeElement(AD)
2504. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeElement(CD)
2506. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
TypeElement(ST)
2508. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2510. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2512. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2514. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2516. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeElement(PN)
2518. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeElement(TEL)
2520. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeElement(CD)
2522. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeElement(CD)
2524. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2526. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2528. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2530. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2532. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
TypeElement(ST)
2534. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeElement(AD)
2536. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeElement(CD)
2538. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeElement(II)
2540. MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
TypeElement(ST)
2542. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2544. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2546. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2548. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2550. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeElement(CD)
2552. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeElement(CD)
2554. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeElement(CD)
2556. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2558. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2560. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2562. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2564. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
2566. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
2568. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
2570. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
2572. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2574. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2576. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2578. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2580. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
2582. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
2584. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
2586. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
2588. MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
2590. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2592. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2594. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2596. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2598. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeElement(CD)
2600. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2602. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2604. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2606. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2608. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeElement(RTO)
2610. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeElement(RTO)
2612. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
TypeElement(ST)
2614. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeElement(CD)
2616. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2618. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2620. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2622. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2624. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeElement(CD)
2626. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeElement(CD)
2628. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeElement(RTO)
2630. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
TypeElement(ST)
2632. MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeElement(CD)
2634. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics
Definition

9.8.2.4

Short9.8.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2636. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2638. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2640. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2642. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem
Definition

The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)

ShortThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
Control1..1
TypeElement(CD)
2644. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value
Definition

The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)

ShortThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
Control1..1
TypeElement(CD)
2646. MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status
Definition

The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)

ShortThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
Control0..1
TypeElement(CD)
2648. MedicinalProduct.PharmaceuticalProduct.PhPIDSet
Definition

9.8.2.6

Short9.8.2.6
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2650. MedicinalProduct.PharmaceuticalProduct.PhPIDSet.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2652. MedicinalProduct.PharmaceuticalProduct.PhPIDSet.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.PhPIDSet.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2654. MedicinalProduct.PharmaceuticalProduct.PhPIDSet.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2656. MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets
Definition

This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)

ShortThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
Control1..1
TypeElement(II)
2658. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration
Definition

9.8.2.3

Short9.8.2.3
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2660. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2662. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2664. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2666. MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration
Definition

The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)

ShortThe route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)
Control1..1
TypeElement(CD)
2668. MedicinalProduct.ProductClassification
Definition

9.2.2.4

Short9.2.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2670. MedicinalProduct.ProductClassification.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2672. MedicinalProduct.ProductClassification.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.ProductClassification.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2674. MedicinalProduct.ProductClassification.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2676. MedicinalProduct.ProductClassification.CodeSystem
Definition

The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)

ShortThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
Control1..1
TypeElement(CD)
2678. MedicinalProduct.ProductClassification.Value
Definition

The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)

ShortThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
Control1..1
TypeElement(CD)
2680. MedicinalProduct.ProductCross-Reference
Definition

9.2.2.7

Short9.2.2.7
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2682. MedicinalProduct.ProductCross-Reference.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2684. MedicinalProduct.ProductCross-Reference.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.ProductCross-Reference.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2686. MedicinalProduct.ProductCross-Reference.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2688. MedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference
Definition

This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)

ShortThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
Control1..1
TypeElement(II)
2690. MedicinalProduct.ProductCross-Reference.ReferencedProductType
Definition

This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)

ShortThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
Control0..1
TypeElement(CD)
2692. MedicinalProduct.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2694. MedicinalProduct.TherapeuticIndication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2696. MedicinalProduct.TherapeuticIndication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.TherapeuticIndication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2698. MedicinalProduct.TherapeuticIndication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2700. MedicinalProduct.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
TypeElement(ST)
2702. MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeElement(CD)
2704. MedicinalProduct.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeElement(CD)
2706. MedicinalProduct.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeElement(CD)
2708. MedicinalProduct.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeElement(CD)
2710. MedicinalProduct.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeElement(PQ)
2712. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2714. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2716. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2718. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2720. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeElement(CD)
2722. MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeElement(CD)
2724. MedicinalProduct.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2726. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2728. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.TherapeuticIndication.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2730. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2732. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
2734. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
2736. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
2738. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
2740. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
2742. MedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
2744. MedicinalProduct.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2746. MedicinalProduct.TherapeuticIndication.UndesirableEffects.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2748. MedicinalProduct.TherapeuticIndication.UndesirableEffects.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.TherapeuticIndication.UndesirableEffects.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2750. MedicinalProduct.TherapeuticIndication.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2752. MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
TypeElement(ST)
2754. MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeElement(CD)
2756. MedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeElement(CD)
2758. MedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeElement(CD)
2760. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2762. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2764. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2766. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2768. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
2770. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
2772. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
2774. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
2776. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
2778. MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)
2780. MedicinalProduct.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2782. MedicinalProduct.UndesirableEffects.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2784. MedicinalProduct.UndesirableEffects.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.UndesirableEffects.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2786. MedicinalProduct.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2788. MedicinalProduct.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
TypeElement(ST)
2790. MedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeElement(CD)
2792. MedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeElement(CD)
2794. MedicinalProduct.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeElement(CD)
2796. MedicinalProduct.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2798. MedicinalProduct.UndesirableEffects.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2800. MedicinalProduct.UndesirableEffects.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on MedicinalProduct.UndesirableEffects.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2802. MedicinalProduct.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2804. MedicinalProduct.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeElement(CD)
2806. MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeElement(PQ)
2808. MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeElement(PQ)
2810. MedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeElement(CD)
2812. MedicinalProduct.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeElement(CD)
2814. MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeElement(CD)